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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014