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Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384318
First Posted: June 29, 2011
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
  Purpose
In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.

Condition Intervention
Surgical Patients Intubated With Cuffed ETT Other: Manometer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Joseph D. Tobias, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Cuff pressure [ Time Frame: Baseline ]
    cm H2O measured by manometer


Enrollment: 200
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cuffed ETT
Patients intubated with cuffed endotracheal tubes.
Other: Manometer
Measuring cuff pressure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients intubated with cuffed ETTs.
Criteria

Inclusion Criteria:

  • Having a cuffed ETT placed per treating anesthesiologist
  • < 18 yrs of age.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384318


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Joseph D Tobias, MD Nationwide Children's Hospital