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ETT Cuff Leak: TV Ratios

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02768831
Enrollment
50
Registered
2016-05-11
Start date
2020-08-17
Completion date
2022-06-28
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedures, Operative

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.

Interventions

OTHERCPAP

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.

OTHERTidal volume

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.

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intracuff pressureImmediately following intubationDifference in intracuff pressure measured after inflation with CPAP and inflation with TV.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026