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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:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01384318
First received: June 27, 2011
Last updated: November 29, 2012
Last verified: November 2012
  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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Cuff pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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