We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Blind Maneuver to Position an Endobronchial Blocker

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364142
First Posted: June 2, 2011
Last Update Posted: June 22, 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):
Jae-Hyon Bahk, Seoul National University Hospital
  Purpose
One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice. We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic bronchoscopy.

Condition Intervention
One Lung Ventilation Endobronchial Blocker Thoracic Surgery Fiberoptic Bronchoscopy Procedure: endobronchial blocker

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Blind Maneuver to Position an Endobronchial

Further study details as provided by Jae-Hyon Bahk, Seoul National University Hospital:

Enrollment: 56
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
thoracic surgery
Patients undergoing thoracic surgery in which one lung ventilation is needed.
Procedure: endobronchial blocker
After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.

Detailed Description:

The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to locate the blocker without the aid of FOB in patients undergoing thoracic surgery.

After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase. And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the position of the blocker is recorded and we will evaluate the success rate of proper blocker position.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing thoracic surgery
Criteria

Inclusion Criteria:

  • patients undergoing thoracic surgery who need one lung ventilation

Exclusion Criteria:

  • patients who have a lesion in trachea or mainstem bronchi
  • severe tracheal deviation
  • patients who do not agree to informed consent
  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): NCT01364142


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Jae-Hyon Bahk, PhD, MD Seoul National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae-Hyon Bahk, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01364142     History of Changes
Other Study ID Numbers: JHBahk_bronchial blocker
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: June 22, 2012
Last Verified: June 2012


To Top