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Completed

NCT Number: NCT02461017

Endotracheal Tube Audible Leak Test

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.

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Key information

Conditions

Anesthesia Intubation Complication Mechanical Ventilation Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assess for Audible Endotracheal Leak

Other

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.

Assess for Endotracheal Leak with direct visualization under rigid bronchoscope

Other

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.

Primary outcomes

  1. Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak

    Time frame: 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 outcomes

  1. Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's

    Time frame: one year.

    Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

Endotracheal Tube Audible Leak Test: What is the Accuracy?

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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