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NCT04184778 Clinical Trial

Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness

Sore Throat Clinical Trial

Official title:
Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04184778
Other study ID # RHN_DMK_06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2020

Study information
Verified date June 2021
Source Vendsyssel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

How tube size affect patient's experience of postoperative sore throat and hoarseness

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.

Recruitment information / eligibility
Status Completed
Enrollment 261
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Smaller tube size
Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.

Locations
Country Name City State
Denmark North Denmark Regional Hospital Hjørring
Denmark Aalborg University Hospital Thisted

Sponsors (1)
Lead Sponsor Collaborator
Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 7 days
Primary 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. 7 days
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