Endotracheal Tube Audible Leak Test

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endotracheal Tube Audible Leak Test: What is the Accuracy?

Conditions
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Anesthesia Intubation Complication, Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Assess for Audible Endotracheal Leak
* Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube. Exclusion Criteria: Known history of subglottic stenosis Known history of recurrent croup Known history of endolaryngeal or subglottic lesions Parents refusal of participation in study

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endotracheal Leak<br>Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope | Other: Assess for Audible Endotracheal Leak<br>* 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.<br>Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak | Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet. | one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's | Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's. | one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, ventilation, airway, airleak