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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285804
First Posted: January 28, 2011
Last Update Posted: January 31, 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
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: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Joseph D. Tobias, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT01285804


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

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
First Submitted: January 26, 2011
First Posted: January 28, 2011
Last Update Posted: January 31, 2012
Last Verified: January 2012