Clinical Trials Directory

Trials / Completed

CompletedNCT02768831

ETT Cuff Leak: TV Ratios

Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Nationwide Children's Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCPAPSealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch.
OTHERTidal volumeThe ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0.

Timeline

Start date
2020-08-17
Primary completion
2022-06-28
Completion
2022-06-28
First posted
2016-05-11
Last updated
2024-06-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02768831. Inclusion in this directory is not an endorsement.