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

NCT ID: NCT01285804

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Adenoidectomy Tonsillectomy Adenotonsillectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cuffed ETT

Group Type ACTIVE_COMPARATOR

Cuffed ETT

Intervention Type OTHER

Kimberly Clark

Uncuffed ETT

Group Type ACTIVE_COMPARATOR

Uncuffed ETT

Intervention Type OTHER

Kimberly Clark

Interventions

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Cuffed ETT

Kimberly Clark

Intervention Type OTHER

Uncuffed ETT

Kimberly Clark

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.

Exclusion Criteria

* Airway anomalies or cardiac conditions that have the potential for a complicated anesthesia induction.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chairman Dept. of Anesthesiology & Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB10-00487

Identifier Type: -

Identifier Source: org_study_id