Thermosoftening of Double-lumen Tube to Reduce Sore Throat

December 16, 2012 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat

The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

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

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

  • Preoperative hoarseness or sore throat
  • History of upper airway diseases
  • Anticipated difficult airway
  • Anesthesia time longer than 6 hours

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-thermosoftening
Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
Procedure: non-thermosoftening
Intubation is performed with a double-lumen tube put into normal saline at room temperature.
Experimental: thermosoftening
Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
Procedure: thermosoftening
Intubation is performed with a double lumen tube put into warm normal saline (40°C).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative hoarseness
Time Frame: up to 3 days after surgery
up to 3 days after surgery
postoperative sore throat
Time Frame: up to 3 days after surgery
up to 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Vocal cord injuries
Time Frame: up to 1 day after surgery
up to 1 day after surgery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 16, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHBahk_DLT_thermosoftening

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.

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