NCT02981537

Brief Summary

The purpose of this study is to find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

December 1, 2016

Last Update Submit

July 12, 2017

Conditions

One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

  • location of endobronchial blocker

    immediately after the insertion of blocker by fiberoptic bronchoscope

Study Arms (2)

two-staged

EXPERIMENTAL

positioning endobronchial blockers to appropriate bronchus with two-staged methods

Device: two-staged endobronchial blocker insertionDevice: single-staged endobronchial blocker insertion

single-staged

ACTIVE COMPARATOR

positioning endobronchial blockers with traditional single-staged methods

Device: two-staged endobronchial blocker insertionDevice: single-staged endobronchial blocker insertion

Interventions

two-staged endobronchial blocker insertionDEVICE

positioning endobronchial blockers in two-staged method

single-stagedtwo-staged
single-staged endobronchial blocker insertionDEVICE

positioning endobronchial blockers in traditional single-staged method

single-stagedtwo-staged

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for lung resection

You may not qualify if:

  • refuse to enroll
  • patients with lesions involving mainstem bronchi
  • patients with anomalies in tracheobronchial tree

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Min S, Yoon S, Han J, Seo JH, Bahk JH. A novel technique of blindly positioning bronchial blockers for one-lung ventilation: a prospective, randomized, crossover study. J Cardiothorac Surg. 2025 Jan 9;20(1):50. doi: 10.1186/s13019-024-03276-8.

    PMID: 39780264DERIVED

Study Officials

  • JH Bahk

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

KR(1)