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Transcript of beyondpvalue.com FT... · Web view2018/07/20 · Tracheostomy is a procedure generally suggested...
COMPARATIVE STUDY ON THE OUTCOME OF EARLY
TRACHEOSTOMY VS LATE TRACHEOSTOMY IN PATIENTS WHO
ARE ON PROLONGED MECHANICAL VENTILATION IN INTENSIVE
CARE UNIT
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1 INTRODUCTION
2 REVIEW OF LITERATURE
3 AIMS & OBJECTIVES
4 MATERIALS & METHODS
5 RESULTS
6 DISCUSSION
7 CONSULATION
8 LIMITATIONS
9 BIBLIOGRAPHY
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Glossary Abbreviations
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INTRODUCTION
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INTRODUCTION
Tracheostomy is a procedure generally suggested for patients who are critically ill and require
prolonged mechanical ventilation. Tracheostomy is a surgical procedure where an alternate
airway is created for the patients. This procedure plays a crucial role reducing co-morbid
conditions like duration of stay at the hospital, pneumonia1 which occurs due to the assisted
ventilation and also bringing down the mortality rates. There are two major techniques for
tracheostomy, including open surgical tracheostomy (ST) and percutaneous dilatational
tracheostomy (PDT).
Other forms of assisted ventilation during emergencies and when the patients are critically ill and
unable to maintain the normal respiration is endotracheal intubation. On the other hand extended
tracheal tube intubation time may lead to serious complications involving damage to the trachea
and larynx.2 Tracheostomy can practically be an advantageous alternative3 for intubation, by
reducing the airway resistance and requirement of sedatives, on the same time tracheostomy is
also not without any complications. Complications like vocal cord dysfunction, stomal
granulation, persistent tracheal fistula, and scarring are persistent for the patients undergoing
tracheostomy4.
There is a huge number of tracheostomies performed on patients with mechanical ventilation. A
study from the UK have reported an estimate of 15000 tracheostomy procedures annually5. The
median time taken to perform of a tracheostomy was found to be 10 to 11 days after admitting I
the ICU, but on the other hand, upto 13% of the tracheostomies were placed within 2 days of
admission6. Even after tracheostomy being a crucial decision, that is to be taken during the
emergencies, there is a lack of definite and robust set of guidelines for the procedure.
Recommendations have been made at a consensus conference that, translaryngeal intubation for
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patients need of the artificial airway up to 10 days and performing tracheostomy after 21 days of
intubation7. But the timing of tracheostomy is still disputed.There lies an ambiguity on when
exactly to carry out the procedure and the factors that are to be taken into consideration. The
appropriate timing to carry out tracheostomy can affect various parameters like cost of
admission, duration of stay in the hospital, morbidity and mortality.
When assessed for the secondary outcomes, studies have reported a significant decrease in
average days spent in the intensive care unit with early tracheostomies. There was no evidence
suggesting that either treatment led to a lower likelihood of pneumonia8. In a similar study9,
which tried to address the controversy had indicated that early tracheostomy had no influence on
mortality, pneumonia, or laryngotracheal pathology rates in trauma patients
Studies10-12 conducted on the timing of tracheostomy in adult subjects undergoing mechanical
ventilation have documented no difference in mortality or hospital-acquired pneumonia, but
early tracheostomy was associated with significantly decreased duration of mechanical
ventilation and shorter stay in the intensive care unit.
A study carried out for analyzing the cost incurred had demonstrated that across multiple centers,
early tracheostomy, defined as tracheostomy performed within 10 days of tracheal intubation,
considerably has reduced hospital costs based on LOS alone and these results were consistent.
There are studies, which have reported that early tracheostomy offers considerable economic
benefit, and have demonstrated early tracheostomy reduce long term mortality, ventilator
dependent days and ICU stay13. This could be possibly be a result of early tracheostomy
improving lung mechanics and oral hygiene, decreasing pain, decreasing need for sedatives and
improving communication when compared to a ventilator13. Through these studies,
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recommendations were made for a robust cost effectiveness study that would guide the
procedure in future.
Most importantly in cases of trauma patients with severe head or chest injury who need
intubation and mechanical ventilation for a long time often undergo tracheostomy. Physicians
have a responsibility to balance benefits with risks of complications such as bleeding, infection,
nerve injury, and tracheal damage. Furthermore, evidence on the benefits of tracheotomy despite
risks is necessary to influence both the patient’s family and medical providers who are uncertain
about invasive procedures
As in the recent times, there are large number of studies that are being carried out on the current
issue, but are mostly presented with inconclusive results. Through this current study, an attempt
is being made to compare the benefits and adverse effects of early and late tracheostomy and to
possibly ascertain an appropriate time for carrying out the procedure in critically ill patients and
also during emergencies.
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AIMS & OBJECTIVES
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AIMS AND OBJECTIVES:
Aim:
To evaluate and compare the benefits and adverse effects of early and late tracheostomy
in patients who are on mechanical ventilation in ICU setup.
To highlight the benefits of effective post-operative tracheostomy care.
Objectives:
To evaluate the indications and outcome of patients requiring tracheostomy in intubated
patients who are in intensive care unit.
To compare the complications in patients undergoing early and delayed tracheostomy.
To prove the advantages of doing tracheostomy at the appropriate time.
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REVIEW OF LITERATURE
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REVIEW OF LITERATURE
Increasing number of critically ill patients and need for mechanical ventilation
Nazir I Lone and Timothy S Walsh14 have carried out a retrospective cohort study to establish the
incidence and outcomes of prolonged mechanical ventilation in a UK.Out of 8290 ICU
admission episodes, 7848 were included in the analysis. PMV patients used 29.1% of all general
ICU bed days, spent longer in hospital after ICU discharge than non-PMV patients (median 17 vs
7 days, P < 0.001) and had higher hospital mortality (40.3% vs 33.8%, p value = 0.02). For the
region, in which about 70 PMV patients were treated each year, a weaning unit with a capacity
of three beds appeared most cost efficient. From the findings, authors have conclude that,
establishing a weaning unit would potentially reduce acute bed occupancy by 8-10% and could
reduce overall treatment costs.
To determine the characteristics, the frequency and the mortality rates of patients needing
mechanical ventilation and to identify the risk factors, a prospective cohort study was carried out
by Léa Fialkow et al15., among 1,115 patients admitted to the ICU who needed mechanical
ventilation. The mean Acute Physiology and Chronic Health Evaluation II (APACHE II) score
was 22.6±8.3. Independently associated factors were the conditions present at the beginning of
mechanical ventilation, age, acute respiratory distress syndrome, sepsis and chronic obstructive
pulmonary disease. The other conditions that were associated during the course of mechanical
ventilation were acute respiratory distress syndrome, sepsis, and renal, cardiovascular, and
hepatic failures. Based on the findings, authors have concluded that, it was evident that mortality
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rate of patients who required mechanical ventilation was higher, which may have been related to
the severity of illness of the patients admitted to the ICU.
Role of tracheostomy in mechanical ventilation
Marchese S et al16., have reported results of their study one-year survey which evaluated clinical
characteristics, types of tracheostomy and complications in patients. Major complications after
tracheostomy were 2%. 427 tracheostomies were evaluated for de-cannulation, 96 (22.5%) were
closed, 175 patients (41%) were discharged with home mechanical ventilation, 114 patients
(26.5%) maintained the tracheostomy despite weaning from mechanical ventilation and 42
patients (10%) were dead or lost for follow up. The systems for evaluating feasibility of
decannulation were, closure of tracheostomy tube, laryngo-tracheoscopy, use of tracheal button
and down-sizing. Based on the findings, authors have concluded that, even though few major
complications of tracheostomy were reported, a considerable proportion of patients maintain the
tracheostomy despite not requiring mechanical ventilation.
Terragni P et al17., have stated that, orotracheal intubation avoids acute surgical complications
such as bleeding, nerve and posterior tracheal wall injury, and late complications such as wound
infection and tracheal lumen stenosis that may emerge due to tracheostomy tube placement.
Tracheostomy is often considered when mechanical ventilation is expected to be applied for
prolonged periods or for the improvement of respiratory status, as this approach provides airway
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protection, facilitates access for secretion removal, improves patient comfort, and promotes
progression of care in and outside the intensive care unit (ICU).
Yuan CR et al18., have carried out a study to better examine the effect of tracheostomy on clinical
outcome among prolonged ventilator patients in Taiwan. A total of 3880 patients with ventilator
use for more than 14 days between 2005 and 2009 were identified. Among them, 645 patients
with tracheostomy conducted within 30 days of ventilator use were compared to 2715 patients
without tracheostomy on death. The tracheostomy rate was 30%, and 55% of tracheostomies
were performed within 30 days of mechanical ventilation. After adjustments, patients with
tracheostomy were at a lower risk of death during hospitalization (hazard ratio [HR] =0.51; 95%
confidence interval [CI] =0.43-0.61) and 5-year observation (HR = 0.73; 95% CI = 0.66-0.81),
and a lower probability of successful weaning (HR = 0.88; 95% CI = 0.79-0.99). Higher medical
use was also observed in patients with tracheostomy. Authors have finally concluded that
through this study, the beneficial effect for tracheostomy was observed which reciprocated in
reduction of death and also patients with tracheostomy were less likely to wean and more likely
to consume medical resources.
To examine the association between the performance of a tracheostomy and intensive care unit
and postintensive care unit mortality Clec'h C et al19., have carried out a prospective,
observational, cohort study. Of the 2,186 patients included, 177 (8.1%) received a tracheostomy.
Both models led to similar results. Tracheostomy did not improve intensive care unit survival
(model 1, odds ratio, 0.94, 95% confidence interval, 0.63-1.39, p = .74, model 2, odds ratio, 1.12,
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95% confidence interval, 0.75-1.67, p = .59). There was no difference whether tracheostomy was
performed early (within 7 days of ventilation) or late (after 7 days of ventilation). In patients
discharged free from mechanical ventilation, tracheostomy was associated with increased
postintensive care unit mortality when the tracheostomy tube was left in place (model 1: odds
ratio, 3.73; 95% confidence interval, 1.41-9.83, p = .008, model 2: odds ratio, 4.63, 95%
confidence interval, 1.68-12.72, p = .003). Based on the results obtained, authors have concluded
that, tracheostomy did not seem to reduce intensive care unit mortality when performed in
unselected patients but may represent a burden after intensive care unit discharge.
A retrospective study was carried out by Combes A et al.,20 to evaluate the effect of
tracheostomy on intensive care unit (ICU) and in-hospital mortality for patients requiring
prolonged (more than 3 days) mechanical ventilation Non tracheostomized patients had higher
ICU (42% vs. 33%, p = .06) and in-hospital (48% vs. 37%, p = .03) mortality rates and shorter
mechanical ventilation durations and ICU lengths of stay. Performing a tracheostomy (odds ratio,
0.58; 95% CI, 0.37-0.90) was independently associated with a lower probability of ICU death.
No significant differences were detected between the 120 cases and their matched controls
regarding ICU admission and day-3 clinical characteristics. Tracheostomy was associated with
lower risk of ICU (odds ratio, 0.47; 95% CI, 0.24-0.89) and in-hospital (odds ratio, 0.48; 95%
CI, 0.25-0.90) death. In the conclusions, authors have stated that tracheostomy performed in the
ICU for long-term patients on mechanical ventilation was associated with lower ICU and in-
hospital mortality rates.
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To estimate the prevalence of, the risk factors associated with, and the outcome of tracheostomy,
a prospective, observational cohort study was carried out by Frutos-Vivar F et al21., which
included 361 intensive care units from 12 countries. Parameters associated with the performance
of tracheostomy were duration of mechanical ventilation, need for reintubation, and neurologic
disease as the primary reason of mechanical ventilation. The intensive care unit stay of patients
with or without tracheostomy was a median of 21 days Vs 7 days, respectively, and the hospital
stay was a median 36 days Vs. 15 days, respectively. Mortality in the hospital was similar in both
groups (39% vs. 40%, p = .65). Authors have come to a conclusion that, though tracheostomy is
a common surgical procedure in the intensive care unit that is associated with a lower mortality
in the unit but with a longer stay and a similar mortality in the hospital than in patients without
tracheostomy.
Kojicic M et al22., have retrospectively reviewed the medical records of adult Olmsted county,
Minnesota, to assess the incidence and outcomes of tracheostomy in residents, who underwent
tracheostomy A total of Sixty-five patients, underwent tracheostomy for prolonged medical
ventilation, which resulted in an age-adjusted incidence of 13 (95% CI 10-17) per 100,000
patient-years at risk. Forty-six patients (71%) survived to hospital discharge, and 36 (55%) were
alive at 1-year follow-up. Authors have concluded that, there was a considerable incidence of
tracheostomy for prolonged medical ventilation and the presence of COPD was an independent
predictor of 1-year mortality.
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In their article, Lazaridis C et al23., made an attempt to review the general principles of liberation
and the current literature related to neurosurgical patients with primary brain injury Patients who
remain ventilator or artificial airway dependent receive a tracheostomy. The appropriate timing
for the procedure is not well defined and may be different among an inhomogeneous population
of critically ill patients. The criteria for "readiness of extubation" include a combination of
neurologic assessment, hemodynamic, and respiratory parameters. Authors have suggested that,
more studies are required to better assess indicators for extubation readiness, evaluate the
predictors of extubation failure in brain-injured patients, and define the most appropriate timing
for a tracheostomy.
Maheshwari PK et al24., conducted a retrospective study to assess the frequency, indications,
postoperative course and short-term outcome of elective tracheostomy in a Paediatric Intensive
Care Unit (PICU) of Pakistan. Twenty-five patients underwent tracheostomy in last 5 years (2.2
% of all PICU admissions). The most common indication for tracheostomy was prolonged
mechanical ventilation secondary to neurological disease (60%), followed by upper airway
obstruction (40%). Major complications included accidental decannulation (20%) and tube
obstruction (20%). Three patients (12%) developed ventilator-associated pneumonia after
tracheostomy change while persistent bacterial colonization of trachea was observed in 8 patients
(32%). Decannulation was achieved in 40% (10/25). There was no mortality related to
tracheostomy in this study.
Mahmood K, and Wahidi MM.,25 in their study have reported that, percutaneous tracheostomy
with Ciaglia technique is commonly used and rivals the surgical approach. Percutaneous
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technique is associated with decreased risk of stomal inflammation, infection, and bleeding along
with reduction in health resource utilization when performed at bedside. Bronchoscopy and
ultrasound guidance improve the safety of percutaneous tracheostomy. Authors have stated in the
conclusion that, early tracheostomy decreases the need for sedation and intensive care unit stay
but may be unnecessary in some patients who can be extubated later successfully.
To investigate trends in tracheostomy use, timing, and outcomes in the United States, Mehta AB
et al26 have calculated estimates of tracheostomy use and outcomes from the National Inpatient
Sample from 1993 to 2012.Results have shown that, tracheostomy was more common in surgical
patients, men, and racial/ethnic minorities. Age-adjusted incidence of tracheostomy increased by
106%, rising disproportionately to mechanical ventilation use. Over time, tracheostomies were
performed earlier, whereas hospital length of stay declined, discharges to long-term facilities
increased (40.1% vs. 71.9%; P < 0.0001), and hospital mortality declined (38.1% vs. 14.7%, P <
0.0001). Authors have concluded that, the observed drastic increase in discharge of tracheostomy
patients to long-term care facilities may have substantial implications for clinical care, healthcare
costs, policy, and research.
Early and late tracheostomy
There are no specific and standardized definitions for both early as well as late tracheostomy.
Based on the review of previous studies that have been carried out in the past decade, early
tracheostomy was defined as performing tracheostomy within 3 to 10 days of mechanical
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ventilation, whereas late was defined as any time outside the early period, within 7 to 14 days, 14
to 28 days, or 28 days after initiation of mechanical ventilation27.
There is no uniformity in the literature about the definition of “early” tracheostomy. In the
1980s, tracheostomy was considered “early” if it was performed before 21 days of translaryngeal
intubation28. But the timing of tracheostomy has changed over a period of time, and now many
suggest tracheostomy within 2–10 days. This definition of “early” corresponds to that proposed
by the otorhinolarygologists, who have always suggested tracheostomy within several days to
prevent laryngeal injury from even these short intubation periods29.
Indications for early and late tracheostomy
General indications for the placement of tracheostomy include acute respiratory failure with the
expected need for prolonged mechanical ventilation, failure to wean from mechanical
ventilation, upper airway obstruction, and difficult airway secretions.
The most common indications27 for tracheostomy include:
1. Acute respiratory failure and need for prolonged mechanical ventilation
2. Traumatic or catastrophic neurologic insult requiring airway, or mechanical ventilation or
both.
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Early tracheostomy outcomes
Arabi Y et al30., have carried out a prospective study to examine the impact of early
tracheostomy on the duration of mechanical ventilation, ICU length of stay, and outcomes in
trauma ICU patients. Out of the total 653 patients included in the study, 36 (21%) required
tracheostomies, 29 of whom were early and 107 were late. Patients with early tracheostomy were
more likely to have maxillofacial injuries and to have lower Glasgow Coma Scale score.
Duration of mechanical ventilation was significantly shorter with early. Similarly, ICU length of
stay was significantly shorter. Following tracheostomy, patients were discharged from the ICU
after comparable periods in both groups (4.9 + 1.2 days versus 4.9 + 1.1 days). ICU and hospital
mortality rates were similar. Late tracheostomy was an independent predictor of prolonged ICU
stay (>14 days). Based on the study findings, authors have concluded that, early tracheostomy in
trauma ICU patients is associated with shorter duration of mechanical ventilation and ICU length
of stay.
To see if early tracheostomy (fifth day) reduces duration of mechanical ventilation, ICU stay,
incidence of pneumonia and mortality in comparison with prolonged intubation (PI) in patients
with head injury, Bouderka MA et al31 have carried out a prospective study. Randomization was
done in two groups, early tracheostomy group (T group, n = 31) and prolonged endotracheal
intubation group (I group, n = 31). The mean time of mechanical ventilator support was shorter
in T group (14.5 + 7.3) versus I group (17.5 + 10.6) (p value = 0.02). After pneumonia was
diagnosed, mechanical ventilator time was 6 + 4.7 days for ET group versus 11.7 + 6.7 days for
prolonged endotracheal intubation group (p = 0.01). There was no difference in frequency of
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pneumonia or mortality between the two groups. From the results it was evident and the authors
have concluded that, in severe head injury early tracheostomy decreases total days of mechanical
ventilation or mechanical ventilation time after development of pneumonia.
In order to determine if tracheostomy performed before postoperative day 10 improves patient
outcomes, Devarajan J et al32, have conducted a retrospective review of prospectively collected
patient information on adult patients recovering from coronary artery bypass grafting and/or
valve surgery. Patients were divided into 2 groups based on the timing of their tracheostomy,
early (less than 10 days) and late (14 to 28 days). Results showed that, after propensity matching
(n = 114 patients), early tracheostomy was associated with decreased in-hospital mortality
(21.1% vs 40.4%, p = 0.002) and cardiac morbidity (14.0% vs 33.3%, p < 0.001), along with
decreased ICU (median difference 7.2 days, p < 0.001) and hospital (median difference 7.5 days,
p = 0.010) durations. The occurrence of sternal wound infection (6.0% vs 19.5%, p = 0.009) was
less in the early tracheostomy group, but mediastinitis did not differ significantly (3.5% vs 7.0%,
p = 0.24). Based on the results, authors have to come to a conclusion that, tracheostomy within
10 postoperative days in cardiac surgery was associated with decreased length of stay, morbidity,
and mortality.
To test their hypothesis, that timing of tracheostomy for severely injured children would
similarly impact outcomes. Holscher CM et al33 had reviewed the data regarding injured children
who underwent tracheostomy over 10 years of time period. During the study period, 91 patients
underwent tracheostomy following injury. Twenty-nine (32%) patients were less than 12 years
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old, of these, 38% received early tracheostomy. Sixty-two (68%) patients were age 13 to 18, of
these, 52% underwent early tracheostomy. Patients undergoing early tracheostomy had fewer
ventilator days (p = 0.003), ICU days (p = 0.003), hospital days (p = 0.046), and tracheal
complications (p = 0.03) compared to late tracheostomy. There was no difference in pneumonia
(p = 0.48) between early and late tracheostomy. Authors have concluded that, children
undergoing early tracheostomy had improved outcomes compared to those who underwent late
tracheostomy
Szakmany T et al34., have carried a systematic review of randomized trials in patients allocated to
tracheostomy within 10 days of start of mechanical ventilation and were compared with
placement of tracheostomy after 10 days if still required. Results have shown that, tracheostomy
within 10 days was not associated with any difference in mortality (risk ratio = 0.93 (0.83–
1.05)). There were no differences in duration of mechanical ventilation, intensive care stay, or
incidence of VAP. Yet, duration of sedation was reduced in the early tracheostomy groups. More
tracheostomies were performed in patients randomly assigned to receive early tracheostomy (risk
ratio = 2.53 (1.18–5.40)).In the conclusion, authors have stated that they have found no evidence
that early (within 10 days) tracheostomy reduced mortality, duration of mechanical ventilation,
intensive care stay, or VAP. Early tracheostomy leads to more procedures and a shorter duration
of sedation.
Outcomes of late tracheostomy
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Average duration of mechanical ventilation in patients undergoing late tracheostomy was found
to be 24 days11, 35. As reported by studies10 which compared the proportion of patients who died
in ICU with respect to early tracheostomy 34.7% in the late tracheostomy group and it was
higher than the early procedure group11.In a study by Nasim ahmed and Yen-Hong Kuo36, have
reported comparatively higher results, compared to the early tracheostomy group among
parameters like Glasgow Coma scale score, number of units of blood required for blood
transfusion.Other factors which were compared included number of days In ICU, percent to
rehabilitation, duration of stay at the hospital and the total charges incurred or the total
expenditure for the whole procedure.All the reports have higher values, making the early
tracheostomy procedure mmore advantageous than late tracheostomy.
Early Vs late tracheostomy outcomes
A Retrospective clinical study was carried out by Aissaoui Y et al37., to assess the impact of
tracheostomy timing on outcome of critically ill patients requiring mechanical ventilation.
Results from the study have shown that, early tracheostomy was associated with significant
reduction of length of sedation (10 + 3 vs 17+ 5 days, P<0.001), length of MV (21+19 vs 29 + 17
days, P=0.02) and length of stay in ICU (33 + 22 vs 42 +18 days, P=0.042). There were no
differences in prevalence of pneumonia (21% for early tracheostomy group vs 31% for late
tracheostomy group, P=0, 13), weaning from mechanical ventilation (50 vs 36%, P=0.19), and
mortality rates between the 2 groups (38 vs 54%, P=0.15). Authors have concluded that, that
early tracheostomy, was associated with shorter length of sedation, shorter duration of
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mechanical ventilation and shorter ICU length of stay, without affecting weaning from
mechanical ventilation, prevalence of nosocomial pneumonia or survival.
A meta-analysis was conducted by Andriolo BN et al8., to evaluate the effectiveness and safety
of early versus late tracheostomy in critically ill adults predicted to be on prolonged mechanical
ventilation with different clinical conditions. A total of 8 randomized control studies in which (N
= 1977 participants) were included in the study. At the longest follow-up time available in these
studies, evidence of moderate quality from seven RCTs (n = 1903) showed lower mortality rates
in the early as compared with the late tracheostomy group (risk ratio (RR) 0.83, 95% confidence
interval (CI) 0.70 to 0.98; P value 0.03). Authors have finally concluded that, the whole findings
of the study can suggest the superiority of early over late tracheostomy because no information
of high quality is available for specific subgroups with particular characteristics.
Arabi YM et 38 carried out a cohort observational study to examine the potential effects of time to
tracheostomy on mechanical ventilation duration, intensive care unit (ICU), and hospital length
of stay (LOS), and ICU and hospital mortality. Results have shown that, time to tracheostomy
was associated with an increased duration of mechanical ventilation (beta-coefficient = 1.31 for
each day, 95% confidence interval 1.14-1.48), ICU length of stay (beta-coefficient = 1.31 for
each day, 95% CI, 1.13-1.48), and hospital length of stay (beta-coefficient = 1.80 for each day,
95% CI, 0.65-2.94). On the other hand, time to tracheostomy was not associated with increased
ICU or hospital mortality. Authors have concluded that, performing tracheostomy earlier in the
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course of ICU stay might have an effect on ICU resources and could necessitate significant cost-
savings without adversely affecting patient mortality.
A prospective observational study was carried out by Brook A Det al.,39 to compare the clinical
outcomes of early versus late tracheostomy in patients who require prolonged mechanical
ventilation. A cohort of 90 patients who had tracheostomy in the medical intensive care unit were
included in the study. From the total population, 53 patients had early tracheostomy (mean + SD
= day 5.9 +7.2 of ventilation), and 37 patients had late tracheostomy (mean + SD = day 16.7 +
2.9) (P < .001). The mean (+ SD) duration of mechanical ventilation was 28.3 + 28.2 days in the
early-tracheostomy group versus 34.4 + 17.8 days in the late-tracheostomy group (P = .005).
Total cost of hospitalization was significantly lower in the early-tracheostomy group than in the
late-tracheostomy group (P = .001). The timing of tracheostomy was not associated with hospital
mortality. In the conclusions, authors have stated that early tracheostomy was associated with
shorter lengths of stay and lower hospital costs than is late tracheostomy.
Freeman BD et al., to determine the relationship between tracheostomy timing and duration of
mechanical ventilation, intensive care unit length of stay, and hospital length of stay and to
evaluate the relative influence of clinical and nonclinical factors on tracheostomy practice:
Tracheostomy was performed in 2,473 (5.6%) of 43,916 patients analysed. Tracheostomy
patients had a higher survival rate than non-tracheostomy patients (78.1 vs. 71.7%, p < .001) and
underwent this procedure following a median (25th-75th percentile) of 9.0 (5.0-14.0) days of
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ventilatory support. Tracheostomy timing correlated significantly with duration of mechanical
ventilation (r = .690), intensive care unit (r = .610), and hospital length of stay (r = .341, p < .001
for all). At most, 22% of patients were supported via tracheostomy at any given time. Although a
minority, tracheostomy patients accounted for 26.2%, 21.0%, and 13.5% of all ventilator,
intensive care unit, and hospital days, respectively. Authors have concluded that, tracheostomy
timing appears significantly associated with duration of mechanical ventilation, intensive care
unit length of stay, and hospital length of stay.
Griffiths J et al.,40 To compare outcomes in critically ill patients undergoing artificial ventilation
who received a tracheostomy early or late in their The results reported that, early tracheostomy
did not significantly alter mortality (relative risk 0.79, 95% confidence interval 0.45 to 1.39).
The risk of pneumonia was also unaltered by the timing of tracheostomy (0.90, 0.66 to 1.21).
Early tracheostomy significantly reduced duration of artificial ventilation (weighted mean
difference -8.5 days, 95% confidence interval -15.3 to -1.7) and length of stay in intensive care (-
15.3 days, -24.6 to -6.1). Authors have concluded that, in critically ill adult patients who require
prolonged mechanical ventilation, performing a tracheostomy at an earlier stage than is currently
practised may shorten the duration of artificial ventilation and length of stay in intensive care.
A retrospective cohort study was done by Holloway AJ et al41., to associate timing of
tracheostomy with clinical outcomes in PICU patients: Seventy-three patients were analysed
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with a median of 22 days of ventilation prior to tracheostomy. Patient factors associated with
longer pretracheostomy ventilation included congenital heart disease and vasoactive drug use.
Clinical events associated with longer pretracheostomy ventilation included bloodstream
infection, ventilator-associated pneumonia, and cardiac arrest. For patients undergoing early
tracheostomy, ICU and total hospital lengths of stay were 4 days and 4 weeks shorter,
respectively. In the conclusion, authors have stated that a longer duration of ventilation prior to
tracheostomy is associated with increased ICU morbidities and length of stay.
Hsu CL et al42., conducted a study on a total of 163 patients (93 men and 70 women) to assess,
the optimal timing of tracheostomy, and its impact on weaning from mechanical ventilation and
outcomes in critically ill. Patients were classified into two groups, successful weaning (n = 78)
and failure to wean (n = 85). Patients who underwent tracheostomy more than 3 weeks after
intubation had higher ICU mortality rates and rates of weaning failure. The length of intubation
correlated with the length of ICU stay in the successful weaning group (r = 0.70; P < 0.001).
Tracheostomy after 3 weeks of intubation, poor oxygenation before tracheostomy and occurrence
of nosocomial pneumonia after tracheostomy were independent predictors of weaning failure. In
the conclusion, authors have suggested that tracheostomy after 21 days of intubation is
associated with a higher rate of failure to wean from mechanical ventilation, longer ICU stay and
higher ICU mortality.
A prospective randomized study was carried out by Koch T et al43., to examine whether early
tracheostomy improved outcome in critically ill patients. In a period of two years, 100 critically
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ill, predominantly surgical patients were enrolled in the study. A percutaneous dilatational
tracheostomy was performed either early (</=4 days, 2.8 days median) or late (>/=6 days, 8.1
days median) after intubation. Authors could demonstrate that mortality was not significantly
reduced in the early tracheostomy (ET) group in contrast to the late tracheostomy (LT) group. ET
was associated with decreased VAP incidence (ET 38% vs. LT 64%), decreased duration of
ventilation (ET 367.5 h vs LT 507.5 h), and shorter time of hospitalization both in hospital (ET
31.5 days vs LT 68 days) and in ICU (ET 21.5 days vs LT 27 days). It was concluded by the
authors that, despite many advantages like reduced time of ventilation and hospitalization, early
tracheostomy is not associated with decreased mortality in critically ill patients.
To investigate whether early tracheostomy leads to improved outcomes compared with late
tracheostomy, a systematic search was carried out by Liu CC et al44., a total of eleven studies
were included for final analysis. There was a significant decrease in the intensive care unit length
of stay in the early tracheostomy group. There was no significant difference in hospital mortality
(relative risk, 0.84, 95% CI, 0.67 to 1.04, P = .11). A pooled analysis was not performed for the
incidence of pneumonia or length of mechanical ventilation, secondary to considerable
heterogeneity among the studies. None of the studies reporting laryngotracheal outcomes found a
significant difference between the early and late tracheostomy groups, whereas all 3 studies
reporting sedation use found a significant decrease in the early tracheostomy group. From the
findings, authors have come to a conclusion that, early tracheostomy performed within 7 days of
intubation was associated with a decrease in intensive care unit length of stay.
29
A retrospective study was carried out by Moller MG et al45., to determine if early tracheostomy
(ET) of severely injured patients reduces days of ventilatory support, the frequency of ventilator-
associated pneumonia (VAP), and surgical intensive care unit (SICU) length of stay. Results
have reported that the incidence of VAP was significantly higher in the LT group, relative to the
ET group (42.3% vs. 27.2%, respectively, P <.05). Acute Physiology and Chronic Health
Evaluation II scores, hospital and SICU length of stay, and the number of ventilator days were
significantly higher in the LT group. Based on the reported findings, authors have come to a
conclusion that, among patients who required prolonged mechanical ventilation, there was
significant decreased incidence of VAP, less ventilator time, and lower ICU length of stay when
tracheostomy was performed within 7 days after admission to the surgical intensive care unit.
Siempos et al46., in their study, have aimed to assess the benefit of early versus late or no
tracheostomy on mortality and pneumonia in critically ill patients who need mechanical
ventilation, through extensive and systematic literature review. Analyses of 13 trials which were
included in the study showed that all-cause mortality in the intensive-care unit was not
significantly lower in patients assigned to the early versus the late or no tracheostomy group (OR
0.80, 95% CI 0.59-1.09; p=0.16). This result persisted when we considered only trials with a low
risk of bias (511 deaths; OR 0.80, 95% CI 0.59-1.09; p=0.16; eight trials with 1934 patients).
Incidence of ventilator-associated pneumonia was lower in mechanically ventilated patients
assigned to the early versus the late or no tracheostomy group (691 cases; OR 0.60, 95% CI 0.41-
0.90; p=0.01; 13 trials with 1599 patients). Through this study, authors have suggested that early
tracheostomy is not associated with lower mortality in the intensive-care unit than late or no
tracheostomy.
30
In their systematic review and meta-analysis of randomized trials in patients allocated to
tracheostomy, Szakmany T et al47., have reported that, tracheostomy within 10 days was not
associated with any difference in mortality (risk ratio (RR), 0.93 (0.83-1.05)). There were no
differences in duration of mechanical ventilation, intensive care stay, or incidence of VAP.
However, duration of sedation was reduced in the early tracheostomy groups. More
tracheostomies were performed in patients randomly assigned to receive early tracheostomy.
Authors have concluded that, they found no evidence that early (within 10 days) tracheostomy
reduced mortality, duration of mechanical ventilation, intensive care stay, or VAP.
Young D et al48., have carried out an open multicentre randomized clinical trial, to test whether
early vs late tracheostomy would be associated with lower mortality in adult patients requiring
mechanical ventilation in critical care units. A total of 1032 eligible patients were included in the
final analysis. Results have shown that, all-cause mortality 30 days after randomization was
30.8% in the early and 31.5% in the late group (absolute risk reduction for early vs late, 0.7%;
95% CI, -5.4% to 6.7%). Two-year mortality was 51.0% in the early and 53.7% in the late group
(P = 0.74). Tracheostomy-related complications were reported for 6.3% of patients (5.5% in the
early group, 7.8% in the late group). Authors have concluded that, tracheostomy within 4 days of
critical care admission was not associated with an improvement in 30-day mortality or other
important secondary outcomes.
To investigate whether early percutaneous dilational tracheostomy (PDT) can reduce duration of
mechanical ventilation, and to further verify whether early PDT can reduce sedative use, shorten
31
intensive care unit (ICU) stay, decrease the incidence of ventilator associated pneumonia (VAP),
and increase successful weaning and ICU discharge rate, Zheng Y et al49., conducted a
prospective, randomized controlled trial in a surgical ICU. A total of 119 patients were
randomized to either the early PDT group (n = 58) or the late PDT group (n = 61). The
successful weaning and ICU discharge rate was significantly higher in early PDT group than in
late PDT group (74.1% vs. 55.7%, P < 0.05, and 67.2% vs. 47.5%, P < 0.05 respectively). VAP
was observed in 17 patients (29.3%) in early PDT group and in 30 patients (49.2%) in late PDT
group (P < 0.05). There was no significant difference between the two groups in the cumulative
60-day incidence of death after randomization (P = 0.949). From the study findings, authors have
come toa conclusion that, the early PDT resulted in more ventilator-free, sedation-free, and ICU-
free days, higher successful weaning and ICU discharge rate, and lower incidence of VAP, but
did not change the cumulative 60-day incidence of death in the patients.
32
MATERIALS & METHODS
33
Study site: This study was conducted in the Department of…………………………….
Study population: Patients who had indications for tracheostomy in the ICU at
………………… were considered as study population.
Study design: The current study was a prospective observational study
Sample size:
Sampling method: All the eligible subjects were recruited into the study consecutively by
convenient sampling till the sample size is reached.
Study duration: The data collection for the study was done between March 2017 to September
2018 for a period of 1.6 year.
Inclusion Criteria:
1. ICU patients on endotracheal intubation receiving mechanical ventilation.
2. Patients on endotracheal intubation who is not receiving mechanical ventilation.
3. Patients of either sex.
4. Patients above 16yrs of age.
Exclusion criteria:
1. Patient not ready to give informed consent.
2. Patients below the age of 16years.
3. Patient who is already on a tracheostomy tube from an outside hospital.
4. Previous laryngeal pathology.
5. Emergency tracheostomy cases.
34
Ethical considerations: Study was approved by institutional human ethics committee. Informed
written consent was obtained from all the study participants and only those participants willing to
sign the informed consent were included in the study. The risks and benefits involved in the
study and voluntary nature of participation were explained to the participants before obtaining
consent. Confidentiality of the study participants was maintained.
Data collection tools: All the relevant parameters were documented in a structured study proforma.
Methodology:
A prospective observational study was been done with a sample of 144 patients in a tertiary care
center –……………….. in the intensive care unit. Tracheostomy was defined as early if
performed within day 7 of mechanical ventilation and late if performed thereafter. The outcomes
studied were:
Weaning off from ventilator
Weaning off from oxygen
Decannulation
Factors to be studied include : ( 1week, 1 month and 3 months after decannulation)
o Incidence of complications like –
Intubation granuloma
subglottic stenosis
tracheal stenosis
o Quality of voice after decannulation
Voice analysis recorder.
o Duration of intubation and tracheostomy
o Quality of life- (before and after decannulation)
35
• Are you able to move around?
• Are you able to speak on the phone with friends/family?
• Are you able to take oral feeds?
• Are you coughing often?
o Infection rate
o Ability to swallow [post recovery]
INVESTIGATIONS:
Blood: HB% TC, DC, AEC, BT, CT, platelet count, APTT, PT INR ESR, serology, RBS,
RFT, blood grouping, cross matching.
Urine routine
Others:
Bacteriological examination: culture and sensitivity.
Radiological examination:
Plain x ray of neck.
Plain x ray of chest.
Statistical Methods:
36
OBSERVATIONS AND RESULTS
37
RESULTS:
38
DISCUSSION
DISCUSSION:
39
BIBLIOGRAPHY
40
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ANNEXURES
44