EZ-IO Presentation 1

10.01.2007 Copyright Vidacare 2007 Fadel Soliman, Dr.med.univ.

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Advances In Intraosseous Vascular Access

Dr.med.univ. Fadel Soliman


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Presentation Agenda

• Overview (Clinical Need, IO History, Anatomy & Physiology)

• State of the Art 2006 (FDA & CE Cleared IO Devices)

• IO Research

• Specific Patient Experiences

Prospective Multi-Center Trial

Comparative Studies

• The Benefits of IO Access to Emergency Medicine


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The Worldwide Clinical Need


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6.4 Million Patients In The United StatesEmergency Medical Services

68%

17%

15%

Patients that Need IVs - 11,850,000

8,058,000Easy

Impossible1,778,000IV problems= 3,792,000 patients

Difficult2,014,000


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6.4 Million Patients In The United StatesEmergency Department

67%10%

23%

Patients that Need IVs - 8,276,000

5,586,000Easy

Impossible828,000

Difficult1,862,000

IV problems= 2,2,000 patients


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Central Line Complications

Mechanical• Pneumothorax

• Arterial puncture with hematoma

Thrombotic• 15% of patients develop catheter related thrombus

• Causes catheter blockage

Infection

• Incidence suggests need for caution


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History of intraosseous access IO has endured for more than 65 years as a safe and effective alternative to IV

Reports of over 4,000 adult patients treated during the 1940’s and 50’s

IO Access became a lost art for 40 years because no civilian EMS service

existed to utilize the technique

“Re-discovered” in 1985 by James Orlowski MD while on a trip to India

Established standard of care in Pediatric Advanced Life Support

Recently adopted standard of care in American Heart Association and European

Resuscitation Council guideline revisions


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AHA and ERC Guidelines

IO should be early second line choice for vascular access following 2-3

attempts at a peripheral IV in adults and first line choice for pediatrics

The ET tube is no longer recommended for drug delivery

Central lines are discouraged

CDC report indicates 9% infection rate with central lines in US

Infections associated with 10% mortality and cost of $25k/infection

Central line placement causes unnecessary delay in drug delivery in resuscitation

setting


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Anatomy of intraosseous access


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Thousands of small veins lead from the medullary space to the central circulation T430 RevA


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Lets Put Pain in ProspectiveLets Put Pain in Prospective


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Intraosseous access: Is it painful?


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Why Lidocaine? Anesthetic vs. Analgesic

• Pain associated with IO infusion is related to stimulation of pressure sensors (nerve fibers) in the medullary space

• Lidocaine inhibits stimulation of those sensors and the propagation of signals along the efferent pain fibers

• Pain management with analgesic agents can cause systemic effects and may not eliminate local pain

• Analgesics alter the perception of pain while anesthetics block sensation

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The Right Amount of Lidocaine

Medical Director must authorize appropriate dosage rangeM-216 RevA


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The Right Amount of Pressure

• The pressure in the medullary space is approximately 1/3 of the patients arterial pressure

• Pressurizing fluids for infusion is required to obtain maximum flow rates

• For aggressive fluid resuscitation a rapid infuser may increase flow rates

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Regulate fluid delivery

for ALL patients and take

patient condition into

account with amounts

delivered

Infuse fluids with pressure

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The Right Flush

• The IO space is filled with a thick fibrin mesh

• The medullary space must be pressure flushed to obtain maximum flow rates

• A minimum of 10ccs is required for initial bolus

• Flush must overcome initial resistance felt with bolus administration

• More than one flush may be required to achieve maximum flow rate

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No Flush = No FlowSyringe FLUSH catheter with 10 ml of a sterile solution

Syringe FLUSH catheter

• Prime and use extension set

• Reminder: Patients responsive to pain may require 2% preservative free Lidocaine intraosseously

• PRIOR to syringe flush

• Some patients may require multiple syringe flushes

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Pressure and Flow Rates

• With a pressure bag or infusion pump, IO flow rates are similar to IV Tibial similar to a 20 gauge catheter

Humeral similar to a 16 gauge catheter

• Flow rates for infusions given through an IO with a 300 mm pressure infuser

50 cc – 100cc/ min

Unit of blood in approximately 15 - 30 minutes

• Syringe bolus infusions can be completed in seconds

• Initial rapid 10 cc saline bolus dramatically increases IO flow rates

• With a pressure bag or infusion pump, IO flow rates are similar to IV Tibial similar to a 20 gauge catheter

Humeral similar to a 16 gauge catheter

• Flow rates for infusions given through an IO with a 300 mm pressure infuser

50 cc – 100cc/ min

Unit of blood in approximately 15 - 30 minutes

• Syringe bolus infusions can be completed in seconds

• Initial rapid 10 cc saline bolus dramatically increases IO flow rates

NO FLUSH = NO FLOWNO FLUSH = NO FLOWNO FLUSH = NO FLOWNO FLUSH = NO FLOW


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Infusion of MedicationWhich Drugs can be given?

Any medications that can be safely injected into a peripheral IV can likewise be safely injected IO

What Dose?

IO and IV doses are identical

Flow Rates (A rapid 10 cc saline bolus must be given prior to any infusion):

To maintain optimal IO flow, pressure of 300 mm Hg should be applied to the infusion bag or the pump

Lab Testing: 5 cc of blood can be aspirated from an IO device and

placed into a heparin-coated syringe for standard laboratory testing


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The Right Site

Site selection is dependent upon:

• Absence of contraindications• Accessibility of the site• Ability to monitor and secure the

site• Desired flow rates

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Pediatric EZ-IO Insertion

• Pediatric insertion requires a gentle grip and a soft touch

• One size does not fit all - Consider tissue depth in needle selection

• Be cautious of driver recoil – release the trigger when you feel the “pop” or give

• Always use a stabilizer on newborns and infants

Caution!

Caution!

Recoil!

Recoil!

3- 39 kg usage

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IO Indications• Cardiac arrest• Status epilepticus• Shock Trauma• Arrhythmia• Dehydration• Burns• Drug overdose• DKA (diabetic)• End stage renal disease• Stroke• Myocardial infarction

IV access is often difficult or impossible in these

situationsIO is the AnswerIO is the Answer

• Coma• Head Injury• Anaphylaxis• Congestive heart failure• Dialysis• Emphysema• Respiratory arrest• Hemophiliac crisis• Sickle Cell crisis• Pediatric shock• Chest pain


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Contraindications for EZ-IO Access

• Fracture (targeted bone)

• Previous orthopedic procedures near insertion site•Prosthetic Limb or joint

• IO within past 24 hours (targeted bone)

• Infection at the insertion site

• Inability to locate landmarks or excessive tissue

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Potential Complications for most IO devices• Extravasation

• Compartment syndrome

• Dislodgement

• Fracture

• Failure (Device or user in origin)

• Pain

• Infection

Retrospective Analysis in pediatrics and adults suggests

that infection rates are < 0.6%

Precise Insertion & Placement of the IO Device is Imperative for Success


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FDA & CE Cleared IO Devices

• Cook/Jamshidi / Illinois Sternal

Primarily used for pediatrics

• FAST - 1

Designed for adult sternum

• B.I.G. Bone Injection Gun

Projects a needle set into adult tibia

• EZ-IO

Powers a hollow needle set into the medullary space


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Manually InsertedManually Inserted

Manually inserted hand held infusion needles have been

available for years

Mostly used for infants because

their bones are soft

COOK

JAMSHIDIJAMSHIDI


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FAST-1 (PYNG)


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The Bone Injection Gun (BIG)™The Bone Injection Gun (BIG)™

Adult B.I.G - 15GPediatric B.I.G - 18G


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A New Intraosseous DeviceA New Intraosseous Device

Approved for adult and pediatric use


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The Right NeedleSelection based on:• Weight Range (PD 3-39kg , AD ≥40kg or LD excessive tissue)• Soft tissue depth judged by calibrating your finger• Visualization of the 5mm mark after penetration of the skin• Special situations for use of the LD needle

Excessive soft tissue

Excessive muscle tissue

Edema

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sdralle

Need a fatter baby or a muscle builder. The image should communicate deep tissue not cuteness.


40Length and color are the only differences between Needle Sets

EZ-IO AD 25 mm Needle Set

EZ-IO LD 45 mm Needle Set

5 mm mark

EZ-IO PD 15 mm Needle Set

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41in approved bio-hazard sharps containers

Portable sharps protector

EZ-IO LD sharps protector

Put Stylets Where They Belong . . .

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How IO Benefits Patients and Providers• Saves time

• Saves lives

• Decreases risk of complications

• Saves Money

• Improves Clinical Excellence

• Easy to use (Intuitive)

• Easy to maintain (competency and equipment)


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Study Objective:

To compare - IO bolus vs IV bolus for vascular delivery of drugs during experimental CPR

Subjects: Ten swine (25–30 kg), anesthetized, instrumented & subjected to cardiac arrest and CPR.

IO drug delivery during CPR Kramer C. et al


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Protocol

No treatment: 8 minutes

CPR: 2 minutes

INJECT

BolusEvans Blue/Epinephrine

0.2 mg/ml

BolusICG/Epinephrine

0.2 mg/ml

Tibia Series -1

IV Series -2

Sternum

Cardiac ArrestKCI

Cardiac ArrestKCI


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Appearance time


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Peak Concentrations


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How effective is IO during CPR?


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EZ-IO RemovalMaintain a 90 degree angle

Rotate the syringe clockwise

Gently pull

Maintain 90 degree angle, Rotate clockwise and gently Pull


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The reality of intraosseous access


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The 5 Rights of the EZ-IO

1. The Right Needle

2. The Right Site

3. The Right Amount of Lidocaine

4. The Right Flush

5. The Right Amount of Pressure

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Picture needs to change


53DO NOT SUBMERGE DRIVER AT ANY TIME

Cleaning & Disinfecting

• Wipe clean with moistened cloth

• Spray with anti-microbial solution

• Momentarily depress trigger several times during cleaning

• Clean around drive shaft with cotton applicator – check to ensure nothing has attached to the magnetic tip

• Wipe dry

• Inspect driver and return to case or replace trigger guard

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[email protected]

Thank You!


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Questions

EZ-IO Presentation 1

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