Study to Evaluate Causes of Failure to Extubate

Description of project- This is a prospective chart review to identify factors influencing a
successful extubation event.

Hypothesis- Successful extubation in a pediatric intensive care unit is dependent on
variables, which can be identified and the chances of success predicted. A clinical practice
based upon such a prediction model, will improve the quality of care provided to the
patients.

Type- Prospective chart review .

Procedure- Over 1 year period, all planned extubations in the intensive care unit to be
recorded on a designated form and standard variables charted. All extubation decisions are to
be made by the covering attending physician and at no time, the study protocol will
affect/influence or alter the standard patient care. All data will be collected
retrospectively after the extubation event. All included patients will be assigned a unique
identification number (UID) by the investigator, who will secure the patient identifiers in
an encrypted electronic file. Extubation failure will be defined as reintubation within 72
hours of a planned extubation and will be further classified as early (<12 hours) and late
(12-72 hours) extubation failure. The cause of extubation failure will be recorded (as
identified by the attending physician on service, who is not involved in the study).

Data collection and statistical analysis- The data will be collected on a standard form. The
data collected will be periodically logged in an electronic data base and analyzed.
Investigators will perform an interim analysis at the end of 6 months and a final analysis of
the data at the end of 1 year period. Since this is an observational study, all the
extubations in the time period, will be included. Based on 2010 data collected, for
monitoring unplanned extubations (300 extubations) and considering recent expansion in their
unit, investigators expect about 500 extubations in the time period.

For statistical analysis, group that fail extubation, will be compared, with the group that
was an extubation success. Standard demographics (age, sex), patient disease related factors
(diagnosis, duration of intubation, secretions, sedation level), care factors (CPAP trials,
cuff leak test, use of pre-extubation decadron, p/f ratio prior to extubation), and post
extubation care (post extubation respiratory support, stridor, blood gas) along with any
complication during extubation and reintubation and reasons for reintubation will be
collected and compared. As two groups are being compared, bivariate analyses utilizing
Chi-square tests or univariate logistic regression for categorical variables and Student t
-tests for interval variables, will be done. Based on 9.9% extubation failure rate in 2010,
investigators expect ~50 extubation failures in the time frame. From the preliminary data,
investigators also expect a 40% difference in the primary variables of comparison (age,
secretions, sedation level). For statistical analysis at 95% confidence interval and 80%
power, investigators will be able to detect differences between groups in proportions of
approximately 20% with the expected sample size or differences of 25% with a 99% CI. The
investigators also will conduct multivariate logistic regression analysis using extubation
failure as the dependent variable and calculate the independent odds ratio for significant
predictor variables. Early Vs late extubation failures, will also be compared. From
literature, investigators assume 80% of extubation failures to be early (from their estimate,
40 early extubation failures and 10 late extubation failures, in 1 year period). They do not
expect statistically significant results from the numbers in present trial period, however
they expect to get trends to plan a further study.

Inclusion Criteria:

- All planned extubations in pediatric Intensive care unit

Exclusion Criteria: