A Blind Maneuver to Position an Endobronchial Blocker

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01364142
First received: May 31, 2011
Last updated: June 20, 2012
Last verified: June 2012
  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 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01364142     History of Changes
Other Study ID Numbers: JHBahk_bronchial blocker
Study First Received: May 31, 2011
Last Updated: June 20, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on October 22, 2014