Clincosm LogoSign in Get a demo

A Blind Maneuver to Position an Endobronchial Blocker

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01364142
Collaborator
(none)
56
Enrollment
1
Location
8
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: endobronchial blocker

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.

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Blind Maneuver to Position an Endobronchial
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae-Hyon Bahk, professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01364142
    Other Study ID Numbers:
    • JHBahk_bronchial blocker
    First Posted:
    Jun 2, 2011
    Last Update Posted:
    Jun 22, 2012
    Last Verified:
    Jun 1, 2012

    Study Results

    No Results Posted as of Jun 22, 2012