The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker
The Need and the Effectiveness of Fiberoptic Bronchoscopy for Better Lung Collapse in Vedio-assisted Thoracic Operations Using Endobronchial Blockers
1 other identifier
interventional
112
1 country
1
Brief Summary
The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional bronchoscopic guided EBBs placement, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 23, 2015
CompletedNovember 23, 2015
October 1, 2015
1.1 years
April 28, 2014
June 30, 2015
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical Grading for Lung Isolation
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
10-15 minutes
Time Required for Proper Placement of the Endobronchial Blocker
10-15 minutes
Study Arms (2)
conventional
ACTIVE COMPARATORinsertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
auscultation
EXPERIMENTALinsertion endobronchial blocker by auscultation without conventional bronchoscopic reposition
Interventions
insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy
Eligibility Criteria
You may qualify if:
- Lung separation by endobronchial blockers
You may not qualify if:
- Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
Related Publications (1)
Wang ML, Wang YP, Hung MH, Hsu HH, Chen JS, Yang FS, Cheng YJ. Is fibre-optic bronchoscopy necessary to confirm the position of rigid-angled endobronchial blockers before thoracic surgery? A randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):241-246. doi: 10.1093/ejcts/ezx260.
PMID: 28950380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- YJ Cheng
- Organization
- NTUH
Study Officials
- PRINCIPAL INVESTIGATOR
Ya-Jung Cheng
National Taiwan University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
May 7, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 23, 2015
Results First Posted
November 23, 2015
Record last verified: 2015-10