Endotracheal Tube Audible Leak Test

NCT ID: NCT02461017

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-07
• Study Completion Date: 2017-02-21

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.

Conditions

Anesthesia Intubation Complication; Mechanical Ventilation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endotracheal Leak

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

Assess for Audible Endotracheal Leak

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Madhankumar Sathyamoorthy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Madhankumar Sathyamoorthy, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

References

Suominen P, Taivainen T, Tuominen N, Voipio V, Wirtavuori K, Hiller A, Korpela R, Karjalainen T, Meretoja O. Optimally fitted tracheal tubes decrease the probability of postextubation adverse events in children undergoing general anesthesia. Paediatr Anaesth. 2006 Jun;16(6):641-7. doi: 10.1111/j.1460-9592.2005.01832.x.

Reference Type: BACKGROUND

PMID: 16719880 (View on PubMed)

Finholt DA, Henry DB, Raphaely RC. Factors affecting leak around tracheal tubes in children. Can Anaesth Soc J. 1985 Jul;32(4):326-9. doi: 10.1007/BF03011335.

Reference Type: BACKGROUND

PMID: 4027762 (View on PubMed)

Schwartz RE, Stayer SA, Pasquariello CA. Tracheal tube leak test--is there inter-observer agreement? Can J Anaesth. 1993 Nov;40(11):1049-52. doi: 10.1007/BF03009476.

Reference Type: BACKGROUND

PMID: 8269566 (View on PubMed)

Other Identifiers

2015-0164

Identifier Type: -

Identifier Source: org_study_id