ETT Cuff Leak: TV Ratios | NCT02768831

Studies
ETT Cuff Leak: TV Ratios

NCT02768831

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Surgical Procedures, Operative

Interventions

CPAP
Tidal volume

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2020Actual

Primary Completion Date

Jun 28, 2022Actual

Completion Date

Jun 28, 2022Actual

First Submitted Date

May 10, 2016

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Senthil G. Krishna, Assistant Professor, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cuffed ETT	Experimental		Other: CPAP Other: Tidal volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracuff pressure	Difference in intracuff pressure measured after inflation with CPAP and inflation with TV.	Immediately following intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40913357	Derived	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.

ID	Term
D007320	Inspiratory Capacity
D014797	Vital Capacity
D014109	Total Lung Capacity
D008176	Lung Volume Measurements