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

Tracking Information
First Received Date ^ICMJE	May 31, 2011
Last Updated Date	December 7, 2011
Start Date ^ICMJE	June 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2011)	repositioning success rate [ Time Frame: up to 10 minutes ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 9, 2011)	repositioning success rate [ Time Frame: after 10 minutes ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01371773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 9, 2011)	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
Original Secondary Outcome Measures ^ICMJE (submitted: June 9, 2011)	anatomic parameters [ Time Frame: after 1 hours ] [ Designated as safety issue: No ] tracheal diameter, position of carina, angle between trachea and left mainstem bronchus
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Repositioning Method for Left-sided Double Lumen Tubes
Official Title ^ICMJE	Repositioning Method for Left-sided Double Lumen Tubes Introduced Into Right Mainstem Bronchus
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Airway Morbidity Intubation Complication
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Left-sided double lumen tube Intervention: Procedure: repositioning method for left-sided double lumen tubes
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	50
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01371773
Other Study ID Numbers ^ICMJE	JHBAhk_headrot
Has Data Monitoring Committee	No
Responsible Party	Jae-Hyon Bahk, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top