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Repositioning Method for Left-sided Double Lumen Tubes

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01371773
First received: May 31, 2011
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to devise repositioning method of a left-sided double lumen tube into left mainstem bronchus in case of misplacement into right mainstem bronchus.


Condition Intervention
Airway Morbidity
Intubation Complication
 Procedure: repositioning method for left-sided double lumen tubes

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • repositioning success rate [ Time Frame: up to 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • anatomic parameters [ Time Frame: up to 1 hours ] [ Designated as safety issue: No ]
    tracheal diameter, position of carina, angle between trachea and left mainstem bronchus


Estimated Enrollment: 50
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Left-sided double lumen tube Procedure: repositioning method for left-sided double lumen tubes
When a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing thoracic surgery that requires the placement of left-sided double lumen tubes

Exclusion Criteria:

  • intraluminal lesion of left bronchus
  • very distorted anatomy of tracheobronchial tree
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371773

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

Responsible Party: Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01371773     History of Changes
Other Study ID Numbers: JHBAhk_headrot
Study First Received: May 31, 2011
Last Updated: December 7, 2011
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013