Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01441362
First received: September 25, 2011
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.


Condition Intervention
Laryngeal Injuries
Procedure: 90 degrees rotation
Procedure: 180 degrees rotation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparison of Two Methods for Intubation With Double-lumen Endobronchial Tube to Reduce Laryngeal Injuries

Further study details as provided by Seoul National University Hospital:

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

Secondary Outcome Measures:
  • postoperative sore throat [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 90 degrees rotation
Double-lumen tube intubation with 90 degrees rotation
Procedure: 90 degrees rotation
Double-lumen tube intubation with 90 degrees rotation
Experimental: 180 degrees rotation
Double-lumen tube intubation with 180 degrees rotation
Procedure: 180 degrees rotation
Double-lumen tube intubation with 180 degrees rotation

  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
  • Operation time longer than 6 hours
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01441362

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01441362     History of Changes
Other Study ID Numbers: JHBahk_DLT_180
Study First Received: September 25, 2011
Last Updated: February 16, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014