ETT Cuff Leak: TV Ratios

Not Applicable

Completed

• Conditions: Surgical Procedures, Operative

• Registration Number: NCT02768831
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

In the past 5 years cuffed endotracheal tubes (ETT) have become the standard of care in pediatrics. However, hyperinflation of the cuff can compromise the tracheal mucosal perfusion while an inadequate seal may impact ventilation and potentially increase the risk of aspiration. Hence, the goal after placement of a cuffed ETT is to create a safe and effective tracheal seal. The two ways to measure that are to hold CPAP while listening for an audible leak and measuring the difference between the inspired and expired tidal volumes (TV). This is a prospective study to compare these two methods used to create a tracheal seal and measure the intracuff pressure after a satisfactory tracheal seal is established.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Study Start: 2020-08-17
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children who are scheduled to undergo GA with a cuffed ETT in place.

Exclusion Criteria

• Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intracuff pressure	Immediately following intubation	Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States