Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique

January 6, 2014 updated by: University of California, San Francisco

Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique

The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique.

The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours
  • ASA I-3

Exclusion Criteria:

  • Planned prolonged intubation
  • Planned postoperative ICU admission
  • Non English speaking
  • Mentally impaired
  • Existing tracheal stoma
  • Nasogastric tube in place preoperative
  • Thyroid / intra-oral surgery
  • Previous general anesthesia within the last 2 weeks
  • Use of steroids within one week before surgery (IV,inhaled, oral)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: intervention
Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer
Device: cuff manometer
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
NO_INTERVENTION: control
endotracheal tube cuff will be inflated using standard technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Tracheopharyngeal Symptoms
Time Frame: within 2 hours after extubation
within 2 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (ESTIMATE)

February 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • weottp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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