The Method to Reduce Displacement of Double-lumen Tube

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01413347
First received: August 9, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to devise the method to reduce displacement of a left-sided double-lumen tube during patient positioning.


Condition Intervention
Double-lumen Tube Displacement
Procedure: pillow
Procedure: neutral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Method to Reduce Displacement of Double-lumen Tube During Patient Positioning

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • tracheal displacement [ Time Frame: up to 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bronchial displacement [ Time Frame: up to 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pillow
confirmation of double-lumen tube position with a head on a pillow
Procedure: pillow
bronchoscopic confirmation of double-lumen tube position with a head on a pillow
Experimental: neutral
confirmation of double-lumen tube position in neutral position of a head
Procedure: neutral
bronchoscopic confirmation of double-lumen tube position in neutral position of a head

  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 require the placement of left-sided double-lumen tubes

Exclusion Criteria:

  • intraluminal lesion of left bronchus
  • very distorted anatomy of tracheobronchial tree
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01413347

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):
Responsible Party: Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01413347     History of Changes
Other Study ID Numbers: JHBahk_DLT_pillow
Study First Received: August 9, 2011
Last Updated: December 7, 2011
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on August 19, 2014