NCT01364142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

May 31, 2011

Last Update Submit

June 20, 2012

Conditions

Study Arms (1)

thoracic surgery

Patients undergoing thoracic surgery in which one lung ventilation is needed.

Procedure: endobronchial blocker

Interventions

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.

thoracic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing thoracic surgery

You may qualify if:

  • patients undergoing thoracic surgery who need one lung ventilation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Hong DM, Seo JH, Chang Kim H, Nam K, Bahk JH. A novel maneuver to blindly position bronchial blockers. Minerva Anestesiol. 2013 Oct;79(10):1126-31. Epub 2013 May 29.

Study Officials

  • Jae-Hyon Bahk, PhD, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations