ETT Cuff Leak: TV Ratios

NCT ID: NCT02768831

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2022-06-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Procedures, Operative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cuffed ETT

Group Type EXPERIMENTAL

CPAP

Intervention Type OTHER

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.

Tidal volume

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPAP

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.

Intervention Type OTHER

Tidal 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TV

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Senthil G. Krishna

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40913357 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB16-00222

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.