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

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. Identifier: NCT01384318
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Brief Summary:
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 or disease Intervention/treatment
Surgical Patients Intubated With Cuffed ETT Other: Manometer

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Group/Cohort Intervention/treatment
Cuffed ETT
Patients intubated with cuffed endotracheal tubes.
Other: Manometer
Measuring cuff pressure

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

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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.

Inclusion Criteria:

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

Exclusion Criteria:

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 identifier (NCT number): NCT01384318

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