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

June 7, 2021 updated by: Dorte Melgaard Kristiansen, Vendsyssel Hospital
How tube size affect patient's experience of postoperative sore throat and hoarseness

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hjørring, Denmark, 9800
        • North Denmark Regional Hospital
      • Thisted, Denmark, 7700
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sore throat after intubation
Time Frame: 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.
7 days
Hoarseness after intubation
Time Frame: 7 days
Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vendsyssel Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHN_DMK_06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hoarseness

Clinical Trials on Smaller tube size

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe