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

Primary Purpose

Post Operative Sore Throat, Dysphagia, Hoarseness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cuff manometer
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Sore Throat focused on measuring sore throat, dysphagia, hoarseness, post operative, endotracheal intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention

control

Arm Description

Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer

endotracheal tube cuff will be inflated using standard technique

Outcomes

Primary Outcome Measures

Incidence of Tracheopharyngeal Symptoms

Secondary Outcome Measures

Full Information

First Posted
February 24, 2011
Last Updated
January 6, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01305265
Brief Title
Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique
Official Title
Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Sore Throat, Dysphagia, Hoarseness
Keywords
sore throat, dysphagia, hoarseness, post operative, endotracheal intubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Active Comparator
Arm Description
Endotracheal tube will be adjusted to 22-26 cm H20 pressure immediately post intubation using a cuff manometer
Arm Title
control
Arm Type
No Intervention
Arm Description
endotracheal tube cuff will be inflated using standard technique
Intervention Type
Device
Intervention Name(s)
cuff manometer
Intervention Description
endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
Primary Outcome Measure Information:
Title
Incidence of Tracheopharyngeal Symptoms
Time Frame
within 2 hours after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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