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

Not Applicable

Completed

• Conditions: Hoarseness; Sore Throat
• Interventions: Device: Smaller tube size

• Registration Number: NCT04184778
• Lead Sponsor: Vendsyssel Hospital

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Man tube size 7.0	Smaller tube size	Smaller tube than normal
Woman tube size 6.0	Smaller tube size	Smaller tube than normal

Primary Outcome Measures

Name	Time	Method
Sore throat after intubation	7 days	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	7 days	Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.

Trial Locations

Locations (2)

North Denmark Regional Hospital; 🇩🇰 Hjørring, Denmark

Aalborg University Hospital; 🇩🇰 Thisted, Denmark