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Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533012
First Posted: February 15, 2012
Last Update Posted: February 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
The purpose of this study is to investigate a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs.

Condition Intervention
Thoracic Surgery Procedure: Pressure difference

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Fiberoptic bronchoscopy view [ Time Frame: within 5 min after intubation ]
    1. aucsultation under manual ventilation -> fiberopric bronchoscopy view check
    2. peak inspiratory pressure difference under mechanical ventilation -> fiberoptic bronchoscopy view check


Secondary Outcome Measures:
  • depth of double lumen tube [ Time Frame: within 5 min after checking fiberopitics ]
    1. aucsultation under manual ventilation -> A depth of DLT (incisor)
    2. peak inspiratory pressure difference under mechanical ventilation -> A depth of DLT (incisor)


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pressure difference
Peak inspiratory pressures difference between two lungs
Procedure: Pressure difference
Peak inspiratory pressures difference between two lungs

Detailed Description:
If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory position, peak inspiratory pressure between two lungs is similar or equal when each lumen is sequentially clamped while ventilating each lung with the same tidal volume. We are going to investigate a performance of this method by fiberoptic bronchoscopy view and depth of double lumen tube, and compare with an conventional auscultation method.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status class I, II
  • Use of double lumen tube
  • Normal preoperative pulmonary function study

Exclusion Criteria:

  • COPD
  • Restrictive lung disease
  • CAOD
  • Unstable hemodynamic status
  • Peak inspiratory pressure > 30 mm Hg (Two lung ventilation)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533012


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young Jun Oh, M.D., PhD.    82-2-2228-2420    yjoh@yuhs.ac   
Principal Investigator: Shin Hyung Kim, M.D.         
Sponsors and Collaborators
Yonsei University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01533012     History of Changes
Other Study ID Numbers: 4-2011-0619
First Submitted: February 7, 2012
First Posted: February 15, 2012
Last Update Posted: February 15, 2012
Last Verified: February 2012