Clinical Trials Directory

Trials / Completed

CompletedNCT02461017

Endotracheal Tube Audible Leak Test

Endotracheal Tube Audible Leak Test: What is the Accuracy?

Status
Completed
Phase
Study type
Observational
Enrollment
86 (actual)
Sponsor
University of Mississippi Medical Center · Academic / Other
Sex
All
Age
1 Month – 8 Years
Healthy volunteers
Not accepted

Summary

The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.

Detailed description

The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.

Conditions

Interventions

TypeNameDescription
OTHERAssess for Audible Endotracheal LeakIn supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded.
OTHERAssess for Endotracheal Leak with direct visualization under rigid bronchoscopeIn the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study.

Timeline

Start date
2015-12-07
Primary completion
2017-01-09
Completion
2017-02-21
First posted
2015-06-03
Last updated
2017-07-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02461017. Inclusion in this directory is not an endorsement.