Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)

June 5, 2015 updated by: Edward Ferenczy

Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study

Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.

Description

Inclusion Criteria:

  • cuffed ETT in place on arrival in the ED
  • cuffed ETT placed while in the ED

Exclusion Criteria:

  • ETT cuff electively left deflated by practitioner
  • Uncuffed ETT used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cuffed ETT
Patients that are intubated with a cuffed endotracheal tube.
Device: Cuffed ETT
Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuff pressure
Time Frame: One time in the ED prior to discharge to the ICU
One measurement of the ETT cuff pressure after intubation in the emergency department.
One time in the ED prior to discharge to the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edward Ferenczy

Investigators

  • Principal Investigator: Edward Ferenczy, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

June 7, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB14-00215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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