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Thermosoftening of Double-lumen Tube to Reduce Sore Throat

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626365
First Posted: June 22, 2012
Last Update Posted: December 18, 2012
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.
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
  Purpose
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 Intervention
Hoarseness Sore Throat Vocal Cord Injuries Procedure: non-thermosoftening Procedure: thermosoftening

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital:

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

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

Estimated Enrollment: 154
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01626365


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae-Hyon Bahk, MD, PhD, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01626365     History of Changes
Other Study ID Numbers: JHBahk_DLT_thermosoftening
First Submitted: June 20, 2012
First Posted: June 22, 2012
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
intubation
thermosoftening

Additional relevant MeSH terms:
Pharyngitis
Hoarseness
Dysphonia
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