Endotracheal Tube Audible Leak Test

Completed

• Conditions: Mechanical Ventilation Complication; Anesthesia Intubation Complication
• Interventions: Other: Assess for Audible Endotracheal Leak; Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscope

• Registration Number: NCT02461017
• Lead Sponsor: University of Mississippi Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Study Start: 2015-12-07
• Primary Completion: 2017-01-09
• Study Completion: 2017-02-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endotracheal Leak	Assess for Audible Endotracheal Leak	Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
Endotracheal Leak	Assess for Endotracheal Leak with direct visualization under rigid bronchoscope	Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope

Primary Outcome Measures

Name	Time	Method
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak	one year.	Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's	one year.	Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States