Thermosoftening of Double-lumen Tube to Reduce Sore Throat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01626365
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

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

Condition or disease Intervention/treatment
Hoarseness Sore Throat Vocal Cord Injuries Procedure: non-thermosoftening Procedure: thermosoftening

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
Study Start Date : May 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

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).

Primary Outcome Measures :
  1. Postoperative hoarseness [ Time Frame: up to 3 days after surgery ]
  2. postoperative sore throat [ Time Frame: up to 3 days after surgery ]

Secondary Outcome Measures :
  1. Vocal cord injuries [ Time Frame: up to 1 day after surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01626365

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jae-Hyon Bahk, MD, PhD, professor, Seoul National University Hospital Identifier: NCT01626365     History of Changes
Other Study ID Numbers: JHBahk_DLT_thermosoftening
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital:
double-lumen tube

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
Respiration Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory