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
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
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
NCT ID
NCT01305265
First Posted
February 24, 2011
Last Updated
January 6, 2014
Sponsor
University of California, San Francisco
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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