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

• Sponsor: Vendsyssel Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04184778
• Collaborator: (none)
• Enrollment: 261
• Locations: 2
• Arms: 4
• Actual Duration (Months): 23
• Patients Per Site: 130.5
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sore Throat; Hoarseness	Device: Smaller tube size	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Woman tube size 6.0 Smaller tube than normal	Device: Smaller tube size; Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.
No Intervention: Woman tube size 7.0 Usual tube size
Experimental: Man tube size 7.0 Smaller tube than normal	Device: Smaller tube size; Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.
No Intervention: Man tube size 8.0 Usual tube size

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Denmark Regional Hospital	Hjørring		Denmark	9800
2	Aalborg University Hospital	Thisted		Denmark	7700

Sponsors and Collaborators

• Vendsyssel Hospital

Investigators

• Principal Investigator: Dorte M Kristensen, PhD, North Denmark Regional Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dorte Melgaard Kristiansen, Associate professor, Vendsyssel Hospital
• ClinicalTrials.gov Identifier: NCT04184778
• Other Study ID Numbers: RHN_DMK_06
• First Posted: Dec 4, 2019
• Last Update Posted: Jun 10, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dorte Melgaard Kristiansen, Associate professor, Vendsyssel Hospital: postoperative; Tube size; Patient experience
• Additional relevant MeSH terms: Pharyngitis; Hoarseness; Dysphonia

Study Results

No Results Posted as of Jun 10, 2021