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“I am the senior PFT tech / Respiratory Therapist for the Pulmonary Medicine Clinics at Group Health Cooperative. We have three full PFT labs connected to our three separate Pulmonary Clinics located throughout the Puget Sound region (Seattle, Tacoma and Bellevue). We have used the LiteAire spacers in our labs for almost two years. Our average usage is about 100 LiteAire per lab a month. Our technicians love the LiteAire. With the dispensing box that they come in, storage is not a problem like it used to be with other devices. After their use in the lab, we give them to our patients. We have not seen a change in the response to bronchodilator when compared to the Optichambers and Aerochambers, both with static control.

Group Health is committed to quality healthcare at affordable rates. With that in mind some may ask why we are spending money using the LiteAire. Numerous studies have shown that not using a spacer device when using MDI is essentially a waste of medication. So, while it may be cheaper it is not the quality of care we are known for. We believe our patients are going to "do as we do, not as we say", meaning that if it is important enough for us to spend their money on the LiteAire, then it must be important enough for them to use it too. We use this time to teach and reinforce proper inhaler technique.Our patients love the LiteAire® spacers. Very, very few patients will carry a traditional spacer with them in their purse or pocket whereas they will take a LiteAire with them. Because of this our patients are getting the same quality of treatments away from home as the do at home. Some have even taken to getting rid of their plastic "tube" spacers and using the LiteAire exclusively because they feel that the LiteAire does a better job.

From a professional standpoint, each time I have had a question, the fine people at Thayer have been very helpful and responsive to my questions. I couldn't tell you how they handle problems with the LiteAire because after using thousands of them we have not had a problem with a single one. My guess is that if there ever was an issue I am confident they would continue to surpass our expectations. If there are any particular questions you have please do not hesitate to call or email me.”

Ralph Stumbo Jr. RRT, CPFT Group Health Cooperative Tacoma Specialty Center, Pulmonary Function Lab (253)383-6164 (253)383-6172 fax stumbo.r@ghc.org

“I attended the 2008 conference in Anaheim where I discovered the Lite Aire® product and discovered a price savings of at least $3 over the spacer we were using. I am proud to say that we give a spacer to all ER patients who get an MDI. I feel that with the money we saved thru out this last year, that I paid for my 2009 conference with the savings. In the year we have had these spacers they have been well received by our patients.”

Diana Lane, RRTRespiratory Care ManagerUkiah Valley Medical Center, 275 Hospital Drive, Ukiah, California 95482(707) 462-3111 LaneDW@ah.org

Ed Thomas, MA, RRTDirector, Respiratory Care, Neurodiagnostics and Sleep Lab St. Mary's Hospital, 1601 W. St. Mary's Road, Tucson, AZ 85745520-872-4133 EThomas2@carondelet.org

“We believe that Metered Dose Inhalers (MDI) should be given with a spacer device to minimize large medication droplets from falling on the tongue and being absorbed. All of our bronchodilator studies given in our Pulmonary Function Lab are given with an MDI and a LiteAire® spacer. We also use the LiteAire in our Emergency Center for patients who may be given a bronchodilator by MDI. We have found the LiteAire to be a clinically effective spacer, as well as being cost efficient.We have used the LiteAire® spacer for a few years in both the Pulmonary Lab and the Emergency Center. We have been pleased with its functionality and intend to continue using it to meet our needs.”

“I first saw the Thayer LiteAire spacer at the National Cystic Fibrosis Conference in October of 2007. I had been looking for a product that would deliver medication from a metered dose inhaler with proper disposition to the airways and would provide infection control between patients. I knew immediately that the LiteAire was what I had been searching for. We have been using it in the pulmonary function lab at Central Maine Medical Center for over a year and are very pleased with the results. From an infection control standpoint we could simply use one inhaler per patient which would be more cost effective. However, due to huge variations in patient technique we could not be certain they would receive optimum medication disposition. I have recommended the LiteAire spacer to a large pulmonary group that also performs pulmonary function testing in their office. They are quite happy with it as well.”

Cynthia Carlton, CRT, CPFTCentral Maine Medical Center, Pulmonary-Physiology Lab 60 High Street, Lewiston, Maine 04240207-795-2582

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LiteAire Collapsible MDI Holding Chamber

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Abstract

BackgroundDespite demonstration of equivalent efficacy of beta agonist delivery using MDI with spacer versus nebulizer in asthma patients, use of nebulizer remains the standard of practice. We hypothesize that beta agonist delivery with MDI/ disposable spacer (LiteAire) combination is as effective and low cost alternative than nebulizer delivery for acute asthma.

MethodsProspective, randomized, double blinded, placebo controlled trial in the emergency department (ED) in 60 acute asthma patients. Subjects were randomized to receive albuterol with MDI/spacer combination or nebulizer. The spacer group (N=29) received albuterol by MDI using LiteAire followed by placebo nebulization. The nebulizer group (N=29) received placebo by MDI using LiteAire followed by albuterol nebulization. Peak flows, symptom scores and need for rescue bronchodilator were monitored.

ResultsPatients in the two randomized groups had similar baseline characteristics. The severity of asthma exacerbation, median peak flows, and symptom scores were not significantly different between the two groups. The median improvement in peak flow was 120(75,180)L/min versus 120(80,155)L/min in the LiteAire and nebulizer groups, respectively (p= 0.56). The median improvement in the symptom score was 7(5,9) versus 7(4,9) in the LiteAir and nebulizer groups, respectively (p= 0.78).Median cost of treatment per patient was $10.11 (interquartile range $10.03-10.28) versus $18.26 (interquartilerange $9.88-22.45) in the Lite Aire and nebulizer groups, respectively (p<0.001).

ConclusionBeta agonist delivery with MDI /spacer combination for management of acute asthma is an equally efficacious and more economical alternative to nebulizer delivery.

EFFICACY AND COST COMPARISONS OF BRONCHODILATOR ADMINISTRATION BETWEEN MDI’S WITH A DISPOSABLE SPACER AND NEBULIZER FOR ACUTE ASTHMA TREATMENTSunil Dhuper MD, Alpana Chandra MD, Aziz Ahmed MD, Sabin Bista MD, Ajit Moghekar MD, Rajesh Verma MD, Cynthia Chong MD, Chang Shim MD, Hillel Cohen Dr. PH, Sonia Choksi MDConey Island Hospital: 2601 Ocean Parkway, Brooklyn, NY, USA, 11235

Introduction

Patients with acute asthma are usually treated with nebulized albuterol in the emergency department and in the inpatient setting after admission. An albuterol metered dose inhaler (MDI) with a spacer can be used alternatively. Spacers allow the patient to inhale aerosol from the MDI without the need to coordinate the actuation of MDI and inhalation, a step many patients have difficulty learning. Equivalent efficacy of albuterol MDI and nebulizer has been demonstrated in adults and children with airflow obstruction.

The spacer/MDI combination has been evaluated in the adults with mild, moderate and severe acute asthma in various settings including the outpatient department, inpatient ward, emergency department, and intensive care settings. Although greater bronchodilator response might be expected with a nebulizer because of the higher dose used for nebulization compared with standard MDI inhalers, studies comparing a beta agonist MDI plus a spacer with a beta agonist nebulizer show no difference with respect to clinical response in acute severe asthma and stable chronic asthma. Albuterol administered by a spacer and MDI therefore may be an effective alternative to a nebulizer. It is well tolerated, easy to use, requires smaller doses of medication than a nebulizer and causes fewer side effects in children with moderate and severe asthma. In addition extra pulmonary sympathetic effects such as tremor, anxiety, and arrhythmias were found in one study to be more prevalent in patients receiving nebulized medication compared to MDI/spacer delivered medication.

Even though bronchodilator delivery with Nebulizer requires longer delivery times and greater personnel resources, nebulized albuterol remains the standard of therapy for patients with acute asthma. Despite the demonstrated equivalency and rapid delivery of MDI/spacer combination, the expense of non–disposable commercial spacers has limited their use in the emergency department or the inpatient setting. Inexpensive alternatives, such as a modified mineral water bottle (valveless homemade spacer), or a Zip-lock bag with a mouthpiece inserted into a corner, have been shown to be equally effective. A new inexpensive, disposable, collapsible, dual-valved holding chamber for use with MDI LiteAire, (Thayer Medical, Tucson, AZ) has recently become commercially available for use in the emergency department or inpatient setting for management of acute asthma We hypothesize that albuterol delivered with LiteAire would be an efficient, cost effective alternative to nebulized albuterol treatment for asthma patients in the emergency department, where other commercial spacers are not used due to affordability.

Results

We screened 75 patients who presented to our adult emergency department for an asthma exacerbation. Of 75 patients screened, 5 did not satisfy eligibility criteria and 10 did not consent for participation into the research. The remaining 60 patients were randomized into two study groups, 30 in each. One patient from each group was not included in the outcome analysis because one patient withdrew consent and the other signed out against medical advice, leaving 29 per group for the study sample. Entry characteristics for the two randomized treatment groups were similar in terms of race, intubation history, asthma duration >10 years, steroid administration, peak flow rate and symptom severity score (Table 1). The LiteAire group had a higher percentage of female patients and was somewhat at a higher mean age. Disposition (discharged home or admitted to hospital) was similar between the groups (p = 0.55). One patient in the LiteAire group and two in the nebulizer group were admitted to the hospital (3% vs. 7%), while 28 patients of the LiteAire and 27 of the nebulizer group (97% vs. 93 %) were discharged home at the completion of the study (Table 2).Medians (interquartile range) for increase in peak flow from entry to disposition were similar for the two groups with 120 (75-180) L/min for the LiteAire and 120 (80-155) L/min for the nebulizer group (p=0.56) (Table 2). Symptom severity scores were also similar (p=0.78). At least one rescue bronchodilator treatment was necessary for 24% of the LiteAire group compared to 21 % of the nebulizer group (p=0.75). The median length of ER stay was 2 hours for both groups with an interquartile range of 1.5-3.0 hours for the LiteAire group and an interquartilerange of 1-2.5 hours for the nebulizer group (p=0.78). Neither gender nor race was significantly associated with any outcome (p > 0.34 for all). With 29 participants per group we had > 95% power to detect if the nebulizer was >50% better than LiteAire for either increase in peak flow or decrease in symptom severity score.

The cost analysis for the two groups is summarized in Table 3. Payroll costs (including fringe) for a respiratory therapist (RT) in our institution is on average $40.94 per hour. The RT needs about ten minutes to instruct and demonstrate the use of LiteAire spacer to a patient, just once for the entire ER stay. For the nebulizer group, it requires on an average approximately 12 minutes per treatment. Thus, the cost for the RT time represents the biggest difference in costs between the two groups, with a constant $6.82 per patient in the LiteAire group and a median (interquartile range) of $16.38 (8.19-20.48) for the nebulizer group (p<.001). There is a one-time cost per patient for the delivery system of $2.95 for LiteAire Spacer and $1.50 for nebulizer. Per treatment costs of the medication are $0.17 and $0.19 for LiteAire and nebulizer respectively. Total costs were significantly lower (p < .001) for the LiteAire group with median (IQR) $10.11 (10.03-10.28) compared to $18.26 (9.88-22.45) for the nebulizer group.

Results

Characteristic

LiteAire group(n=29)

Nebulizer Group(n=29)

Totaln=58

p*

Age(in years) (%)<3030-50>50

354124

52417

434116

.15

Females (%) 83 5971 .04

Race (%)African-AmericanCaucasianHispanicOther

387550

523413

455482

.47

Intubation History (%) 10 79 .64

Asthma duration >10 years (%) 76 7978 .75

Steroids administered in ER (%) 59 6260 .79

Peak Flow Rate (L/min) 220 (165-315)

260 (190-360)

250 (180-343)

.37

Symptom score 8 (7-11)

9 (7-11) 9 (7-11) .95

Characteristic LiteAire Group(n=29)

Nebulizer Group(n=29)

Totaln=58

p*

Age(in years) (%) .15

<30 35 52 43

30-50 41 41 41

>50 24 7 16

Females (%) 83 59 71 .04

Race (%) .47African-American 38 52 45

Caucasian 7 3 5

Hispanic 55 41 48

Other 0 3 2

Unknown

Intubation History (%) 10 7 9 .64

Asthma duration >10 years (%) 76 79 78 .75

Steroids administered in ER (%) 59 62 60 .79

Peak Flow Rate (L/min) 220 (165-315)

260 (190-360)

250 (180-343)

.37

Symptom score 8 (7-11) 9 (7-11) 9 (7-11) 95

Outcome*LiteAire (n=29) Nebulizer (n=29) p

Peak Flow Rate Increase (L/min) 120 (75, 180) 120 (80, 155) .56

Symptom Severity Decrease 7 (5, 9) 7 (4, 9) .78Disposition (%)

HomeAdmitted

97%3%

93%7%

.55

Length of Stay in ER (hours) 2 (1.5, 3) 2 (1, 2.5) .78Received Rescue Treatments (%) 24 % 21 % .75

Lite Air Nebulizer pCost of Delivery System* $ 2.95 $ 1.50 —Cost of Medications $ 0.34 (0.26-0.51) $ 0.38 (0.19- .48) .37

Cost of Respiratory Therapist $ 6.82 (6.82-6.82) $16.38 (8.19-20.48) <.001Total cost $10.11 (10.03-10.28) $ 18.26 (9.88-22.45) <.001

ConclusionWe found that in a busy, municipal hospital ER, bronchodilator therapy for

adults with acute exacerbation of asthma can be administered just as efficaciously using the LiteAire device as with a conventional nebulizer. Additionally, it may result in savings in time and effort invested by the respiratory therapist and consequently a savings in total cost for treatment.

Study DesignPatients were randomly assigned to the study group (MDI/LiteAire spacer combination) or control group (Nebulizer).

Codes for the study device were known only to the pharmacist and all personnel involved in patient recruitment and medication delivery were blinded to the randomization. All patients received treatment with both MDI /spacer combination and nebulizer. The LiteAire group (N=30) received 540 mcg of albuterol by MDI (six actuations of 90 mcg/actuation, Warwick Pharmaceutical Corporation, Reno NV) with the spacer (LiteAire) followed by a placebo nebulizer treatment ( 3 ml of .9% normal saline solution every one hour until disposition. The nebulizer group (N=30) received 6 actuations of placebo MDI with spacer (LiteAire) followed by 2.5mg (3ml) Albuterol (Dey, Napa, CA) by Nebulizer (Cardinal Health Edison, NJ) on a similar schedule. MDIs were shaken before each actuation and medication was administered one actuation at a time into the LiteAire spacer. Each actuation was delivered just before inhalation and the aerosol was inhaled from the spacer by 6 tidal breaths. Patients also received rescue treatments of nebulized albuterol as required. Oral or intravenous steroids were administered at the discretion of the ER physician.

A baseline peak flow and a ‘symptom severity score’ were recorded for each patient at the start of the study, and every 1 hour until disposition. Based on each patient’s perception of severity of symptoms, a score of 0-3 was assigned, each for shortness of breath, chest tightness, wheezing and cough (0 for none, 1 for mild, 2 for moderate, 3 for severe), and a totalscore was calculated as the sum of each individual score, allowing a maximum of 12. A higher score reflected a greater severity of symptoms and decreasing score indicated improvement. Both groups were followed for their expiratory peak flow, symptom severity and the number of rescue bronchodilator treatments every hour for a maximum of 6 hours. The triage decision to admit or discharge a patient from the ED was made within 6 hours of enrollment into the study and the study was terminated once the patient was discharged home, or admitted to the hospital. Patients were discharged or admitted based on NAEPP guidelines.

OutcomesThe primary outcomes measured were change in patients’ symptoms and peak flow rates, and disposition (i.e. admission

to hospital or discharge to home from the emergency department). Secondary outcome measures were length of stay in the ED, cost of therapy and the number of rescue treatments. The length of stay was calculated from the time of enrollment into the study until the time the decision was made regarding patient’s disposition. In the case of patients whose stay in the ED was prolonged for reasons other than medical, the time of disposition was taken as the time that they met the criteria for admission to the medical ward or discharge home. Cost analysis for each group included the cost of medication, equipment (spacer vs. nebulizer kit) and labor (time spent by the respiratory therapists in delivering albuterol via nebulizer vs. spacer ).

Table 1a

Table 2

Table 3

Table 1b

AbstractBackground: Though there is a tremendous variability in number of MDI actuations ( 2-12) used in studies comparing beta agonist delivery via MDI/spacer and a nebulizer, literaturesupports the use of 6 MDI actuations. As delivery systems may influence dose output, prior to conducting a clinical efficacy comparison study, it would be prudent to determine the in vitro dose outputs using the two systems.Objective: The purpose of this study was to perform an in-vitro B-agonist dose output comparison between 6 actuations of “MDI with “LiteAire Spacer” versus 1 Unit dose with a “Nebulizer”. Method: A Standard MDI/LiteAire Spacer combination and Nebulizer were tested using the Michigan Instrument Dual Test Lungs driven by a Puritan Bennett 7200 ventilator set at 14 breaths/minute, TV of 600 ml and I:E ratio of 1:4. The LiteAire was tested with 6 MDI actuations, one puff/respiratory cycle and the Nebulizer with one 3-ml vial (0.833mg/ml) AlbuterolSolution. Nebulization with oxygen (8L/min) was run (sputtering time) for five minutes. Each dose deposition filter was washed with 0.05mM KCl with 1% acetic acid buffer and samples were analyzed by UV spectrophotometer, at a wavelength of 276nm ±1nm to calculate the total dose output. The above experiment was repeated for a total of three times (N=3) for both devices.Results: The average total dose output ± Standard Deviation was 176 ± 27 micrograms for 6 puffs of MDI/LiteAire Spacer versus 220 ± 14 micrograms for Nebulizer (p value 0.067), respectively.Conclusion: We recommend using 6 albuterol MDI actuations with LiteAire spacer, when conducting a clinical efficacy study as the in vitro dose outputs using 6 MDI actuations and a unit dose of nebulizer are comparable. We cannot comment on effective Respirable dose output equivalency as particle size distribution studies were not conducted.

In Vitro Comparison of Albuterol Dose Output for Standard MDI with LiteAire Spacer versus Misty Max 10 NebulizerSunil Dhuper MD, Sanjay Arora MD, Aziz Ahmed MD, Alpana Chandra MD ,Cynthia Chong MD, Chang Shim MD, Hillel Cohen Dr Ph, Scott Foss, Sonia Choksi MDSunil Dhuper, Coney Island Hospital: 2601 Ocean Parkway, Brooklyn, NY, USA, 11235

IntroductionThe purpose of this study was to perform an in-vitro B-agonist dose

output comparison between 6 actuations of an MDI with LiteAire Spacer versus 1 Unit dose with a Nebulizer. The total dose output in micrograms using Standard MDI Boot and a LiteAire Spacer Device for albuterol (CFC) (Inhalation Aerosol – IVAX Pharmaceuticals, Inc.) is determined using 6 actuations of medication versus a Misty Max-10 Nebulizer treatment using one unit dose of albuterol sulfate. The amount collected on the filter (AireLifeNonconductive Respiratory Therapy Filter, Bacterial/Viral Retentive) is the total amount of active ingredient (albuterol/albuterol sulfate) summed over all particle sizes which would be delivered to a patient.

A Standard MDI/LiteAire Spacer combination and Nebulizer were tested using the Michigan Instrument Dual Test Lungs driven by a Puritan Bennett 7200 ventilator set at 14 breaths/minute, TV of 600 ml and I:E ratio of 1:4. The LiteAire was tested with 6 MDI actuations, one puff per respiratory cycle and the nebulizer with one 3-ml vial (0.833mg/ml) albuterol solution. Nebulization with oxygen (8L/min) was used for five minutes.

The LiteAire spacer device is used as shown in Fig 1. The LiteAire spacer device is connected to a USP standard aluminum throat model. A filter (Airlife Nonconductive Respiratory Therapy Filter, Bacterial/Viral Retentive) traps the particles on the opposite side of the throat. The flow is created by one lung of a Dual Adult Test Lung while the opposite lung is driven by a Michigan Instrument Dual Test Lungs driven by a Puritan Bennett 7200 ventilator set at 14 breaths/minute, TV of 600 ml and I:E ratio of 1:4. The LiteAire was tested with 6 MDI actuations of albuterol (CFC) ( IVAX Pharmaceuticals, Inc.)For the Misty Max-10 Nebulizer See Fig 2. An oxygen tank is used to power the Misty Max-10 Nebulizer using standard Nebulizer tubing and is connected to a T-connector where one end of the T-connector is left open and the other end is connected to USP standard aluminum throat model. A filter (Airlife Nonconductive Respiratory Therapy Filter, Bacterial/Viral Retentive) traps the particles on the opposite side of the throat. The flow is created by one lung of a Dual Adult Test Lung while the opposite lung is driven by a Michigan Instrument Dual Test Lungs driven by a Puritan Bennett 7200 ventilator set as above. The Nebulizer was used with one 3-ml vial (0.833mg/ml) albuterol solution. Nebulization with oxygen (8L/min) occured for five minutes.

At the end of the simulated treatments each dose deposition captured by filter was washed with 0.05mM KCl with 1% acetic acid buffer and samples were analyzed by UV spectrophotometer, at a wavelength of 276nm ±1nm to calculate the total dose output. The above experiment was repeated for a total of three times (N=3) for both treatment modes.

Method.

Fig 1: Setup with LiteAire Spacer Device Fig 2: Misty Max-10 Nebulizer

ConclusionWe recommend using 6 albuterol MDI actuations with the LiteAire spacer when conducting a clinical efficacy study as the in vitro dose outputs using 6 MDI actuations and a unit dose of nebulizer are comparable. However, a controlled study comparing the two modes of treatment in patients with asthma would be desirable to demonstrate equivalent clinical efficacy.

Experimental Runalbuterol /

albuterol sulfate

LiteAireDose output of

Albuterol in ug per Treatment (One Treatment = six

actuations)

Misty Max-10Dose output of

Albuterol Sulfate in ug per Treatment

1 161.540 204.5282 159.143 230.4963 207.082 224.503

Average Total Dose Output 175.922± 27.013 219.842± 13.597

Results

LiteAire compared with Nebulizer when using simulated albuterol treatments

0

50

100

150

200

250

LiteAire Misty Max-10

Device

mic

rogr

ams

albu

tero

l per

sim

ulat

ed

trea

tmen

ts

In Vitro Comparison of Particle Size Distribution/Respirable Dose for LiteAire Spacer versus Misty Max –10 Nebulizer Using Albuterol.Sunil Dhuper MD, Sanjay Arora MD, Aziz Ahmed MD, Alpana Chandra MD ,Cynthia Chong MD, Chang Shim MD, Hillel W. Cohen DrPH, Scott Foss, Sonia Choksi MDNorth Central Bronx Hospital, 3424 Kossuth Avenue, Bronx, New York 10467An Affiliate of The Albert Einstein College of Medicine

Introduction

Despite tremendous variability in the number of MDI actuations (2-12) used in studies comparing beta agonist delivery via MDI/spacer and one unit dose ampule with a nebulizer, there is increasing literature support based on clinical trials for the use of 6 MDI actuations. As delivery systems influence the inhaled dose, it would be prudent to determine the in vitro dose outputs using the two systems prior to conducting a clinical efficacy comparison study between MDI/Spacer and nebulizer. In a prior in-vitro study, we have demonstrated no significant difference in the β-agonist total dose output between 6 actuations of MDI with LiteAire Spacer versus 1 unit dose ampule with a nebulizer. However, as particle size distribution was investigated with the two delivery systems, respirable dose output equivalency between the two systems remains undetermined. Therefore, the objective of this study is to compare the emitted dose particle size distribution and effective respirable dose between 6 actuations of albuterol MDI with LiteAire Spacer versus 1 unit dose ampule of a nebulizer.

Discussion

This study demonstrates that using the breath simulation technique there is no significant difference in the total dose output using 6 actuation of albuterol MDI spacer versus 1 unit dose of nebulizer albuterol. Even though the difference in the respirable fraction between the two modes of delivery using ACI was significant, there was no difference in the total dose output in the effective respirable dose calculated using the breath simulation studies. We also determined that the total dose deposition using ACI with the two modes of delivery was not significantly different and well in line with the method using the breath simulated techniques.

We used Oxygen at a flow rate of 8 LPM for nebulizing albuterol, a standard practice for acute asthma in the emergency department. We determined that the impact of using oxygen instead of room air on the cut off diameter in the ACI is negligible. The cut off diameters for the ACI are dependant on the viscosities of gas used with the impactor. The viscosity of air is 0.018centiPoise while that of 100% oxygen is 0.020centiPoise. The concentration of oxygen and the respective viscosity when delivered at 8 LPM, with ACI operating at 28.3LPM flow was 43% and 0.019centiPoise, respectively. Hence, the difference in viscosities of the two gases used for the two modes of delivery (MDI /Spacer vs. Nebulizer) would be 0.001centiPoise. The impact of this difference on the cutoff diameters of ACI and therefore the respiratory particle size would be negligible.

The optimal time for nebulization has been reported in the literature. In a study by Malone et al, it was determined that aerosolization past the sputtering point did not increase albuteroldelivery. The study observed an abrupt decline in aerosol output that always corresponded to the nebulizer sputtering with no change in the albuterol output between 30 to 60 seconds after the sputtering time for three different volumes (1.5 ml, 2.5 ml, and 3.5 ml albuterol solutions). We chose 5 minutes nebulization time in our study as this was one minute past the sputtering time.

Conclusion

When conducting a clinical efficacy study comparing MDI/Spacer and one unit dose of albuterol delivered via nebulization, we recommend using 6 albuterol MDI actuations with spacer as the in vitro dose outputs with the two modes are comparable.

Results

The total dose output was found to be 175.9±27.0 µg for 6 actuations of albuterol delivered to a LiteAire Spacer via MDI versus 219.8±13.6 µg for a Misty Max 10 with T-piece. The percent respirable fraction (defined as the total mass on plates # 3-7 indicating a size range of 4.7-0.4 μm) was found to be 90.26±1.51% for LiteAire and 81.68±0.66% for the Misty Max 10 (p<0.001).. The particle size distributions are shown in Figure 3. Table 1 summarizes the ACI results. The MMAD was 2.05±0.03 for the LiteAire versus 1.49 ± 0.05 for the Misty Max 10 (p<0.0001) and the GSD was 1.64±0.03 for the LiteAire versus 2.25±0.06 for the Misty Max 10 (p<0.001). The effective respirable dose (total dose output from the breath simulation studies * respirable fraction in micrograms) was 158.79+24.38 micrograms with the LiteAire vs. 179.57+11.11 micrograms for the Misty Max 10 ( p=0.27)

Materials and Methods

To determine the total dose output, a test device was attached to a USP throat model feeding into a filter connected to a Michigan Instrument Dual Test Lung System. The lung was driven by a Puritan Bennet 7200 Ventilator set at 14 breaths/minute, tidal volume (TV) of 600 ml and inspiratory to expiratory (I:E) ratio of 1:4. With LiteAire, an albuterol MDI (CFC Inhalation Aerosol – IVAX Pharmaceuticals, Inc.) was actuated at the beginning of inhalation for 6 respiratory cycles (n=6 actuations) and with the nebulizer (Misty Max 10), one 3-ml vial (0.833mg/ml) of albuterol solution was delivered over five minutes. O2 to the Nebulizer was set at a pressure of 50-Psi and a flow of 8 LPM. Each filter was washed with 0.05mM KCl with 1 % acetic acid buffer to collect the deposited drug. Dosage was determined using a UV spectrophotometer, at a wavelength of 276 nm. Both devices were tested 3 times each.Particle size was determined using an Andersen 8-Stage Cascade Impactor(ACI) with USP throat. The ACI was operated at 28.3 LPM. A filter for collection of particle was placed after the last plate of the ACI instead of a terminal filter inside the impactor. A TSI flow meter was connected between the ACI and vacuum pump. For the spacer unit (Figure 1), the vacuum pump was turned on for at least 60 seconds. Six doses of medication were dispensed at the rate of one actuation of albuterol MDI everyten seconds. For the T-nebulizer, setup using the Misty Max 10 (Figure 2), the vacuum pump was turned on for at least 60 seconds and one 3-ml vial (0.833mg/ml) albuterol solution was delivered over five minute period using O2 at 8 L/min to the nebulizer. Each plate and the filter were washed separately with 10ml of 0.05 mM KCl with 1% acetic acid solution to obtain 9 samples. The 9 samples underwent analysis to quantify the dose of albuterolusing a UV spectrophotometer (λ=276 nm). The above experiment was repeated for a total of three times (N=3), for both devices.

IntroductionValved holding chambers (VHCs) assist many patients with the coordination of pressurized metered-dose inhaler (pMDI) medication delivery. However, when an MDI is actuated into a holding chamber, some fraction of the drug output deposits inside the device, which reduces the dose of drug delivered to the patient, and can change the particle size distribution. Some of this drug loss through plastic holding chambers can be attributed to static attraction between drug particles and the chamber walls. In this study, the MDI drug output and particle size distribution characteristics of three VHCs were compared. The three VHCs evaluated included one collapsible, disposable VHC made from non-static paperboard (LiteAire, Thayer Medical), and two VHCs made from rigid polymer (AeroChamberPlus, Monaghan Medical; and OptiChamber Advantage, Respironics).

Materials and MethodsAlbuterol sulfate (Proventil HFA, Key Pharmaceuticals) was used as the test MDI drug throughout this study. For particle size distribution analysis, one of each of the three VHCs (as shown in Figure 1) was attached to an Andersen cascade impactor using a 28.3 L/min vacuum. Each VHC received 15 actuations of Proventil HFA. Drug collected on the impactor plates was eluted with 9 mLof 1 M KCl buffer, and the resulting solutions read via UV/Vis spectroscopy at 276 nm.

Figure 1. Devices tested (n=3 for each)

Materials and Methods (continued)For the drug output analysis, five of each of the VHCs(n=5) were evaluated. The testing apparatus (shown in Figure 2) consisted of a USP throat model connected to a ventilator (Harvard Apparatus) simulating tidal breathing of 750 mL at 12 breaths/min and 1:1 I:E. Each VHC received six MDI actuations, each at the beginning of an inhalation. Drug was collected on a filter downstream of the throat model, was eluted with 18 mL of 1 M KClbuffer, and was read at 276 nm.

ResultsThe results are summarized in Table 1. The albuterol sulfate particle size distributions from the three VHCs(shown graphically in Figure 3) were similar, with nearly identical MMADs and respirable output fractions. In terms of drug output per actuation (shown graphically in Figure 4), the outputs of the LiteAire (75± 7 µg, 69% of 108 µg/actuation canister output) and the AeroChamber Plus (69 ± 4 µg, 64% of canister output) were not significantly different, but were both significantly larger than the output of the OptiChamber(57 ± 3 µg, 53% of canister output).

Results (continued)

Table 1. Results Summary

ConclusionsUnder the conditions tested, the paperboard LiteAireprovided drug delivery performance that was either statistically equivalent to or superior to the rigid plastic VHCs evaluated. Based on these results, the LiteAireappears to offer an effective, lower cost alternative to plastic holding chambers, particularly for single-patient, single-use applications.

Metered-dose inhaler output comparison between a collapsible paperboard holding chamber and two rigid plastic chambers

Carl Okeson, Ph.D., Paul McGowen, RRTThayer Medical Corporation, Tucson, Arizona, USA

AARC 2006: 52nd International Respiratory Congress, Las Vegas, NV. December 11-14, 2006Respiratory Care; November 2006, Vol. 51, No. 11, pg. 1322

Mass of Drug Delivered per Actuation -- P ro v e n til H F A

5 7

6 97 5

0

10

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40

50

60

70

80

90

OptiChamber AeroChamber Plus LiteAire

ug

dru

g d

eliv

ered

per

act

uat

ion

Figure 1. AeroChamber Plus, LiteAire, OptiChamberAdvantage

Figure 2. Drug output testing apparatus

Breathing simulator

USP throat model

Drug collection filter

Holding Chamber

Figure 3. Particle size distributions of albuterol sulfate(Proventil HFA)

Figure 4. Mass of albuterol sulfate delivered per MDI actuation (108 µg/dose from canister alone)

Metered Dose Inhaler Particle Size Distribution of Proventil HFA

0%5%

10%15%20%25%30%35%40%45%50%

10.0-9.0

9.0-5.8

5.8-4.7

4.7-3.3

3.3-2.1

2.1-1.1

1.1-.65

.65-.43

< 0.43

Aerodynamic Diameter Range (um)

% o

f D

rug

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llect

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OptiChamber AeroChamber Plus LiteAire

IntroductionValved holding chambers (VHCs) are widely prescribed to patients for whom coordinated breathing is difficult. For such patients, there may be a brief time lapse between metered-dose inhaler (MDI) actuation into the VHC and inhalation, during which time drug can deposit and be lost inside the VHC chamber. To simulate such uncoordinated breathing, our study compared the drug mass delivered per MDI actuation after a two-second delay by four VHCs: one collapsible device made from paperboard (LiteAire®, Thayer Medical), and three devices made from rigid polymer (AeroChamber Max® and AeroChamber Plus®, Monaghan Medical Corp.; and OptiChamberAdvantage®, Respironics). Using these results and the unit cost of each VHC, a cost-to-performance ratio was calculated for each device.

Materials and MethodsFive of each of the four VHCs (n=5) were evaluated using a USP throat model attached via 22 mm tubing to a Harvard Apparatus large animal ventilator simulating tidal breathing of 750 mL at 12 breaths/minute and 1:1 I:E. Eight actuations of albuterol sulfate were delivered to each VHC from a pre-primed and shaken MDI canister. After each MDI actuation there was a two-second pause prior to inhalation.

Materials and Methods (continued)Drug delivered through each VHC was captured on a filter connected just downstream of the throat model, eluted by rinsing twice with an 18 mL aliquot of 1 M KCl buffer, and quantified via ultraviolet spectroscopy at 276 nm. Drug mass delivered per MDI actuation was calculated as the mean of five unit results for each VHC tested. Device performances were compared via two-tailed T-tests with p < 0.05 indicating a significant difference between VHCs.

ResultsThe results are summarized in Table 1. The drug mass per MDI dose delivered by the AeroChamber Max (67 µg/dose) was significantly larger than the LiteAire (55 µg/dose), the OptiChamber Advantage (52 µg/dose), and the AeroChamber Plus (48 µg/dose), which were not significantly different from each other. When device cost was factored in, the LiteAire was significantly more efficient than the other three VHCs, costing $0.05 per µg of drug delivered, compared to $0.16 for the AeroChamber Max, $0.20 for the OptiChamberAdvantage, and $0.21 for the AeroChamber Plus.

Results (continued)

Table 1. Results Summary

ConclusionsUnder the conditions tested, the AeroChamber Max offered drug mass delivery performance that was significantly higher than the other VHCs. When device cost was considered, the LiteAire yielded significantly lower device cost per drug mass delivered than the three plastic VHCs. This metric may be of importance for short-term VHC applications in which both device cost and performance are of interest.

A Performance and Cost Comparison of Four Valved Holding Chambers During Simulated Uncoordinated Breathing

Carl Okeson, Ph.D., Paul McGowen, RRTThayer Aerosol Laboratory, Tucson, Arizona, USA

AARC 2007: 53rd International Respiratory Congress, Orlando, Fl. December 1-4, 2007Respiratory Care; November 2007, Vol. 52, No. 11, pg. 1622

Figure 1. Optichamber Advantage, AeroChamber Max, LiteAire, AeroChamber Plus

Figure 2. Drug output testing apparatus

Breathing simulator

USP throat model

Drug collection filter

Holding Chamber

Figure 3. Mass of albuterolsulfatedelivered by VHCs per MDI actuation (mass delivered by MDI mouthpiece alone = 108 µg)

Figure 4. Cost-to-performance ratio: VHC cost per µg albuterolsulfate delivered

Metered Dose InhalerAlbuterol Sulfate Mass Delivered/Actuation

6755 52 48

0

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90

AeroChamberMax

LiteAire OptiChamberAdvantage

AeroChamberPlus

ug

Alb

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rol

SO

4/D

ose

*

Cost-To-Performance Ratio:VHC Cost per ug Albuterol Sulfate Delivered

$0.16

$0.05

$0.20 $0.21

$0.00

$0.05

$0.10

$0.15

$0.20

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$0.30

AeroChamberMax

LiteAire OptiChamberAdvantage

AeroChamberPlus

VH

C C

ost

/ug

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ered

(U

S$)

#

^

Multiple Sizes: The MiniSpacer Dispenser/Adapter is available in two standard size configurations.

The Dual-Spray MiniSpacer® MDI Dispenser/Adapter offers an

effective and affordable way to administer MDI medication to

ventilated patients. With two size configurations to choose

from, the MiniSpacer can be placed in various locations within

the circuit, or used in conjunction with a resuscitator bag. It

minimizes deadspace at the endotrachael tube, and eliminates

ddrainage problems inline. The MiniSpacer performs like a spacer

with the cost-effectiveness of an adapter.

22mm OD/ID

22mm OD/OD

Extended UniversalCanister Port on22mm Devices1

• Clean, Ready to Use• Latex Free• For Single Patient Use Only

Metered Dose Inhaler Dispenser/Adapter

PUB0100 Rev. C © 2009 Thayer Medical Corporation

4575 S. Palo Verde Rd. Tucson, AZ 85714 • 800.250.3330 • www.thayermedical.com • info@thayermedical.com

Universal Adapter:Tapered neck willaccept moststandard smallvolume nebulizers.

The Thayer Valved TeeTM Adapter makes it simple to deliver aerosolized medication to your ventilated patients. Used in conjuction with a with a small volume nebulizer (SVN), the Valved Tee offers a safe and effective way to introduce the aerosol into the circuit. Unlike other non-valved tee adapters that require time-consuming and ppotentially hazardous breaks in the system, the Valved Tee is a permanent part of the ventilator circuit. Its unique valve opens and closes as the nebulizer is inserted and removed.

Multiple Sizes: The Valved Tee Adapter is available in fourstandard size configurations.

Spring loaded valve:Opens and closes as one insertsand removes the nebulizer.

• Clean, Ready to Use• Latex Free• For Single Patient Use Only• Change with the circuit

PUB0200 Rev. A © 2009 Thayer Medical Corporation

TM

Quake®:Mucus Clearance Device

The Quake® is designed to meet the demanding mucus clearance needs of a variety of different types of patients, including: •Long-term, sputum-producing respiratory diseases

•Short-term, sputum-producing respiratory infections

©Copyright 2007, Thayer Medical Corporation. All rights reserved.Quake® is a registered trademark of Thayer Medical Corporation. QK07-6 rev. A

The Quake® is an innovative and unique device that provides mucus clearance therapy in a portable, easy-to-use, handheld device.

The Quake®’s soft touch handle allows the patient to regulate rotation frequency and vary percussive pressure differentials within the lungs during both inhalation and exhalation. The Quake® provides optimum performance in any patient position and offers effective results due toits “Flow Independent” design. The Quake® truly allows for individualized therapy that meets each patient’s mucus clearance needs (www.thayermedical.com/quake.htmwww.thayermedical.com/quake.htm).

DisassembledQuakQuake ® view. view.

❍ Position-Independent

❍ Flow-Independent

❍ Patient Controlled by Rotation of Handle

❍ Percussion on Inhalation and Exhalation

❍ Portable

❍ Hand-Held

❍ Fits Standard 22mm Face Mask

ice that table,

ate rotation the lungs optimum

ults due tondividualized

❍ Position-Independent

❍ Flow-Independent

❍ Patient Controlled by Rotation of Handle

❍ Percussion on Inhalation and Exhalation

❍ Portable

❍ Hand-Held

❍ Fits Standard 22mm Face Mask

ThayerThayerThayer ®

Easy to clean: The Quake®’s simple, two-part design enables the user to easily and quickly disassemble and reassemble the Quake for cleaning. It can be cleaned with soap and water, boiled in water, or washed in a dishwasher. The Quake® can also be put in a Quick-Clean™ Micro Steam™ bag and steam cleaned in the microwave.*

Thayer Medical4575 S. Palo Verde Rd., Ste. 337Tucson, Arizona 85714-1961(800) 250-3330www.thayermedical.comMEDICALMEDICAL

Ordering Information

Part Number 1297

For more information, call Thayer Medical at 800-250-3330or e-mail us at sales@thayermedical.com

Feel the power.Experience the sensation.

Outer HousingOuter HousingOuter BarrelOuter Barrel

With Opposing VanesWith Opposing Vanes 22mm Mouthpiece 22mm Mouthpiece

Internal VanesInternal Vanes

Soft TouchSoft TouchHandleHandle

* "Respiratory Equipment Cleaning and Disinfection Guidelines." The Children's Hospital-Denver. Headley, Aree, Dolan,Susan A., Lucas, Trent. 3 September 2004. November 2004 http://www.thechildrenshospital.org/share/policy/HospitalChart.pdf

Copyright 2004. The Children's Hospital Denver

Quick Clean ™ and Micro-Steam ™ are trademarks of MedelaMedela is a registered trademark of Medela

Turn HandleTurn HandleWhile InhalingWhile Inhalingand Exhaling.and Exhaling.

Page 1 of 2PUBQK200808/Rev. B

Q. Who may benefit from using the Quake?A. Individuals suffering from various mucus producing respiratory diseases.

Q. Does the Quake work on exhalation only?A. No, the Quake provides percussion in the lungs during both inhalation and exhalation.

Q. Does the user need to remove the Quake from their mouth during inhalation?A. No, since the Quake works on both inhalation and exhalation, the Quake may remain in the

user’s mouth during the inhalation and exhalation cycles.

Q. Does the Quake require the user to exhale rapidly during the exhalation phase?A. No, the Quake is flow independent, allowing the user to exhale at any given flow rate and

tidal volume during the therapy to create percussion differentials within the lungs.

Q. Does the user need to hold the Quake in a specific position during therapy?A. No, the Quake is position-independent and the user may be in any position – sitting, standing

or lying down.

Q. How fast does the user need to turn the handle during therapy?A. The frequency of handle rotation can vary depending on the user’s needs. By rotating the

handle quickly, a higher percussion frequency is generated with less pressure differentials in the lungs. During slower handle rotation, a greater pressure differential is produced at a lower percussion frequency. The user may alter both the rate of inhalation/exhalation and the speed of the handle rotation to find the combination which produces the best personal result.

Q. Should the user suppress a cough during therapy?A. Yes, for best results, the user should suppress the desire to cough during the treatment cycles.

Q. What should the user do if the treatment does not produce a cough?A. After removing the Quake from the mouth, the user should exhale forcefully to help loosen

the secretions. If this does not trigger a productive cough, the user should attempt a “huff cough to help force the secretions from the airways.

Q. Are there different versions of the Quake for adults and children?A. No, there is no need for different versions because the Quake design operates independent of

the user’s flow rate and tidal volume.

Q. Does the Quake contain natural latex?A. No, neither the Quake nor its packaging contains natural latex.

MEDICAL800. 250.3330• www.thayermedical.com4575 S. Palo Verde Rd., Suite 337 • Tucson, AZ 85714 • USA

AIRWAY CLEARANCE DEVICEPractitioner frequently asked questions

Page 2 of 2PUBQK200808/Rev. B

Q. Does the Quake have any internal parts?A. No, the Quake has two parts: the outer housing (blue body) that contains the mouthpiece and

the inner housing (gray barrel) that attaches to the soft touch handle.

Q. How is the Quake disassembled for cleaning? A. The Quake consists of two simple parts which pull apart for cleaning and are easily

reassembled. Please consult the instructions for use for detailed information.

Q. How is the Quake cleaned?A. After disassembling, the Quake may be cleaned in soap and water, boiled in water, washed in

the dishwasher or steam cleaned in a Quick-Clean™ Micro Steam™ bag and cleaned in the microwave* (*“Respiratory Equipment Cleaning and Disinfection Guidelines.” The Children’s Hospital Denver. Headley, Aree, Dolan, Susan A., Lucan, Trent. 3 September 2004. November 2004 http://www.thechildrenshospital.org/share/policy/Hospital/Chart.pdf).

Q. How often should the Quake be cleaned?A. Once a week or more frequently as needed.

Q. After cleaning the Quake, may others use the device?A. The Quake is intended for single patient use only.

Q. Can the Quake be sterilized?A. No, sterilization is not recommended.

Q. Are there any clinical studies using the Quake?A. Thayer Medical has been approached by several researchers worldwide who plan to conduct

a range of scientific and clinical studies involving the Quake. We are providing assistance as requested by these researchers.

Q. Can a standard face mask be used with the Quake?A. Yes, the Quake fits a standard 22mm face mask.

Q. Does the Quake require a prescription?A. Yes, the Quake is a legend device requiring a prescription or order from a licensed

practitioner.

Q. Is the Quake reimbursable?A. Yes, the following are the reimbursement codes for airway clearance devices.

CPT Codes – Treatment or Service94667 Initial Evaluation, Non-Electric, Oscillator Positive Expiratory Device, Any type.94668 Subsequent Treatment, Non-Electric, Oscillator Positive Expiratory Device, Anytype.

HCPCS Code- DeviceE0484 Non-Electric, Oscillator Positive Expiratory Device, Any type.

MEDICAL800. 250.3330• www.thayermedical.com4575 S. Palo Verde Rd., Suite 337 • Tucson, AZ 85714 • USA

Figure 2. Pressure wave testing apparatus

Breathing simulator USP throat model Pressure sensor

Data acquisition board Handle-turning motor (Quake only)

IntroductionMany airway-obstructed patients with small lung capacities use handheld percussive devices as part of their treatment regimens. When breathed through, the Acapella® (Blue; Smiths Medical), the Flutter® (AxcanScandipharm), and the Quake® (Thayer Medical), generate pressure pulses in the airways of the patient to loosen mucus. In this study, we compared the strength of the pressure pulses (as measured by mean pressure-wave amplitude), and vibration frequencies generated by these devices during simulated low-volume tidal breathing.

Devices TestedThree of each of the three handheld devices (n=3) were tested (as shown in Figure 1). Each device was evaluated at three settings (detailed in Table 1), representing a wide range of performance characteristics. The Acapella was tested at an exhalation time of 3 seconds, as per manufacturer’s instructions. For the Flutter and Quake, exhalation times were not specified by the manufacturers; both were tested at 2-second exhalation times, which was identified as the most comfortable rate by several users.

Figure 1. Devices tested (n=3 for each)

Table 1. Settings evaluated for each device

Materials and MethodsThe devices were attached via a USP throat model and flexible tubing to a modified Harvard Apparatus (Holliston, MA) large animal ventilator simulating tidal breathing of 500 mL and 750 mL at 1:1 I:E. Resulting pressure waves were collected with Honeywell (Morris Township, NJ) ASDX series pressure sensors, and analyzed in Excel. Device performances were compared via two-tailed T-tests; p <= 0.05 indicated a significant difference.

ResultsThe results are summarized in Table 2. Of the three devices, the Quake had the widest vibration frequency range at the settings evaluated. At both the 750 mLand 500 mL breath volumes, the best setting of the Quake generated vibrations with significantly larger amplitudes than the best settings of the Acapella or Flutter. The Quake was the only device to generate vibrations during inhalation. Representative graphs of the pressure waves and vibration amplitudes generated by the three devices at 750 mL are shown in Figures 3a and 3b, respectively.

Results (continued)

Table 2. Results Summary

(a)

(b)

Figure 3. Representative pressure waves generated at 750 mL breath volume. (a) Raw pressure waves. (b) Moving vibration amplitudes.

ConclusionsUnder the conditions evaluated, the Quake generated significantly stronger pressure pulses than both the Acapella and Flutter. This should translate into more vigorous airway percussion, and therefore more effective secretion loosening for patients with low tidal volumes. The Quake also demonstrated the widest range of vibration frequencies, which should allow the patient more control over the vibrations delivered to the airways.

The Percussive Characteristics of the Acapella, Flutter and Quake During Low-Volume Tidal BreathingCarl Okeson, PhD, Paul McGowen, RRT

Thayer Medical Corporation, Tucson, Arizona, USAChest 2007: American College of Chest Physicians, Chicago, Ill. October 20-25, 2007

Chest; October 2007, 132, 608a

Vibratory Pressure Waves @ 750 m L Breath Volume

-25

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Acapella QuakeFlutter

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Exhalation

Percussion Am plitudes @ 750 mL Breath Volume

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Exhalation

Features:

• 175 cc holding chamber

• MDI boot adapter accommodates all standard MDI mouthpieces

• Compatible with 22mm connection port face masks

• Dual-valve system for safe and efficient inhalation of medication

• Colored dual inhalation-exhalation valve facilitates patient training

• Incorporated coaching whistle alerts the user of improper breathing technique during inhalation

Benefits:

• Boot adapter and mouthpiece easily removed for cleaning

• Reduces common errors associated with MDI use

Thayer Medical4575 S. Palo Verde Rd., Ste. 337Tucson, Arizona 85714-1961(800) 250-3330www.thayermedical.com

©Copyright 2008, Thayer Medical Corporation. All rights reserved.PrimeAire® is a registered trademark of Thayer Medical Corporation. PA08-2 rev.A

Ordering Information

Single Count (Part Number 1114)

For more information, call Thayer Medical at 800-250-3330or e-mail us at sales@thayermedical.com

Cleaning

The PrimeAire is simply cleaned by removing the mouthpiece andMDI boot adapter and washing in warm soapy water. See instructionsfor use.

The PrimeAireholding chamberis a clear solution for effectiverespiratory management.Holding chamber devices, like the PrimeAire, are commonly used with metered dose inhalers (MDI’s) to deliver medication directly to theairways during inhalation. These devices help to improve the direction and deposition of the medication being delivered by an MDI by:

• Extending the mouthpiece of the MDI• Retaining the medication in the chamber

• Maintaining the particles in suspension

ve Removable MDI Boot AdapterRemovable MDI Boot Adapter

Coaching WhistleCoaching Whistle

Dual Inhalation-Exhalation ValveDual Inhalation-Exhalation Valve

Clear RemovableClear RemovableMouthpieceMouthpiece

Exhalation PortsExhalation Ports