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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

June 20, 2012
December 16, 2012
May 2012
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01626365 on ClinicalTrials.gov Archive Site
Vocal cord injuries [ Time Frame: up to 1 day after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Thermosoftening of Double-lumen Tube to Reduce Sore Throat
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hoarseness
  • Sore Throat
  • Vocal Cord Injuries
  • Procedure: non-thermosoftening
    Intubation is performed with a double-lumen tube put into normal saline at room temperature.
  • Procedure: thermosoftening
    Intubation is performed with a double lumen tube put into warm normal saline (40°C).
  • Active Comparator: non-thermosoftening
    Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation.
    Intervention: Procedure: non-thermosoftening
  • Experimental: thermosoftening
    Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation.
    Intervention: Procedure: thermosoftening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01626365
JHBahk_DLT_thermosoftening
Not Provided
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP