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

Tonsillectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285804
• Other study ID #: IRB10-00487
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: January 27, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoidectomy
• Adenotonsillectomy
• Tonsillectomy

Intervention

Other:
• Cuffed ETT
Kimberly Clark
• Uncuffed ETT
Kimberly Clark

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.	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.	4-5 minutes after induction	No