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Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01285804
First received: January 26, 2011
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.


Condition Intervention
Adenoidectomy
Tonsillectomy
Adenotonsillectomy
 Other: Cuffed ETT
Other: Uncuffed ETT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT. [ Time Frame: 4-5 minutes after induction ] [ Designated as safety issue: No ]
    The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation.


Enrollment: 200
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cuffed ETT Other: Cuffed ETT
Kimberly Clark
Active Comparator: Uncuffed ETT Other: Uncuffed ETT
Kimberly Clark

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria:

  • Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285804

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01285804     History of Changes
Other Study ID Numbers: IRB10-00487
Study First Received: January 26, 2011
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013