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
| Type | Name | Description |
|---|---|---|
| OTHER | Assess for Audible Endotracheal Leak | In 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. |
| OTHER | Assess for Endotracheal Leak with direct visualization under rigid bronchoscope | In 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.