NCT01285804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

January 26, 2011

Last Update Submit

January 27, 2012

Conditions

AdenoidectomyTonsillectomyAdenotonsillectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Cuffed ETT

ACTIVE COMPARATOR
Other: Cuffed ETT

Uncuffed ETT

ACTIVE COMPARATOR
Other: Uncuffed ETT

Interventions

Cuffed ETTOTHER

Kimberly Clark

Cuffed ETT
Uncuffed ETTOTHER

Kimberly Clark

Uncuffed ETT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)