ETT Cuff Leak: TV Ratios
Minimal Occlusive Pressure With Cuffed ETTs: A Comparison of Two Different Techniques to Ensure a Tracheal Seal
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedStudy Start
First participant enrolled
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedJune 21, 2024
June 1, 2024
1.9 years
May 10, 2016
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Intracuff pressure
Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.
Immediately following intubation
Study Arms (1)
Cuffed ETT
EXPERIMENTALInterventions
Sealing 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.
The 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.
Eligibility Criteria
You may qualify if:
- Children who are scheduled to undergo GA with a cuffed ETT in place.
You may not qualify if:
- Any children with pre-existing tracheal/bronchial anomalies, patients with Down syndrome, patients with C-spine issues.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
Moon K, Kitio SAY, Rice-Weimer J, Tobias JD. Regulation of Intracuff Pressure by Measurement of the Ratio of Expiratory to Inspiratory Tidal Volumes. Paediatr Anaesth. 2025 Nov;35(11):940-945. doi: 10.1111/pan.70045. Epub 2025 Sep 5.
PMID: 40913357DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 11, 2016
Study Start
August 17, 2020
Primary Completion
June 28, 2022
Study Completion
June 28, 2022
Last Updated
June 21, 2024
Record last verified: 2024-06