NCT01885793

Brief Summary

This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

June 18, 2013

Last Update Submit

January 30, 2017

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

  • Intracuff pressure

    Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device.

    Immediately after intubation

Study Arms (1)

Cuffed endotracheal tube

Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT).

Device: Cuffed endotracheal tube

Interventions

Cuffed endotracheal tubeDEVICE

Intubation with a cuffed endotracheal tube (ETT).

Cuffed endotracheal tube

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients that require endotracheal intubation.

You may qualify if:

  • Intubation of trachea with a cuffed endotracheal tube.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Senthil Gopalakrishnan, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 25, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

US(1)