Back to resultsDoes Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
Primary Purpose
Sore Throat, Hoarseness
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Smaller tube size
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat focused on measuring postoperative, Tube size, Patient experience
Eligibility Criteria
Inclusion Criteria:
- Need for intubation
- Elective surgery
- ASA Group I and II
- Understands and speaks Danish
- give one's consent
Exclusion Criteria:
- Known dementia
- SARI score >4
- BMI > 35
- Acute intubation
- attempt intubation > 2
- known with previously difficult intubation
Sites / Locations
- North Denmark Regional Hospital
- Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Woman tube size 6.0
Woman tube size 7.0
Man tube size 7.0
Man tube size 8.0
Arm Description
Smaller tube than normal
Usual tube size
Smaller tube than normal
Usual tube size
Outcomes
Primary Outcome Measures
Sore throat after intubation
Survey - experienced postoperative sore throat after intubation. A scale from 1-4 is used; 1 indicated no sore throat and 4 indicated seriously sore throat.
Hoarseness after intubation
Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04184778
Brief Title
Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
Official Title
Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
How tube size affect patient's experience of postoperative sore throat and hoarseness
Detailed Description
A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.
The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Hoarseness
Keywords
postoperative, Tube size, Patient experience
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Woman tube size 6.0
Arm Type
Experimental
Arm Description
Smaller tube than normal
Arm Title
Woman tube size 7.0
Arm Type
No Intervention
Arm Description
Usual tube size
Arm Title
Man tube size 7.0
Arm Type
Experimental
Arm Description
Smaller tube than normal
Arm Title
Man tube size 8.0
Arm Type
No Intervention
Arm Description
Usual tube size
Intervention Type
Device
Intervention Name(s)
Smaller tube size
Intervention Description
Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.
Primary Outcome Measure Information:
Title
Sore throat after intubation
Description
Survey - experienced postoperative sore throat after intubation. A scale from 1-4 is used; 1 indicated no sore throat and 4 indicated seriously sore throat.
Time Frame
7 days
Title
Hoarseness after intubation
Description
Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.
Time Frame
7 days
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Need for intubation
Elective surgery
ASA Group I and II
Understands and speaks Danish
give one's consent
Exclusion Criteria:
Known dementia
SARI score >4
BMI > 35
Acute intubation
attempt intubation > 2
known with previously difficult intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorte M Kristensen, PhD
Organizational Affiliation
North Denmark Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Denmark Regional Hospital
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Aalborg University Hospital
City
Thisted
ZIP/Postal Code
7700
Country
Denmark
12. IPD Sharing Statement
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Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
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