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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371773
Other study ID # JHBAhk_headrot
Secondary ID
Status Completed
Phase N/A
First received May 31, 2011
Last updated December 7, 2011
Start date June 2011
Est. completion date December 2011

Study information

Verified date December 2011
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary repositioning success rate up to 10 minutes No
Secondary anatomic parameters tracheal diameter, position of carina, angle between trachea and left mainstem bronchus up to 1 hours No
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