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Thermosoftening of Double-lumen Tube to Reduce Sore Throat

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01626365
First received: June 20, 2012
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Postoperative hoarseness [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]
  • postoperative sore throat [ Time Frame: up to 3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vocal cord injuries [ Time Frame: up to 1 day after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626365

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

No publications provided

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
Study First Received: June 20, 2012
Last Updated: December 16, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
double-lumen tube
intubation
thermosoftening

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

ClinicalTrials.gov processed this record on May 22, 2013