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Clinical Trials/NCT01285804
NCT01285804CompletedNot Applicable

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

Nationwide Children's Hospital1 site in 1 country200 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria

  • •Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.

Arms & Interventions

Cuffed ETT

Active Comparator

Intervention: Cuffed ETT (Other)

Uncuffed ETT

Active Comparator

Intervention: Uncuffed ETT (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joseph D. Tobias

Chairman Dept. of Anesthesiology & Pain Medicine

Nationwide Children's Hospital

Study Sites (1)

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