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NCT02133235 Clinical Trial

The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker

Thoracic Diseases Clinical Trial

Official title:
The Need and the Effectiveness of Fiberoptic Bronchoscopy for Better Lung Collapse in Vedio-assisted Thoracic Operations Using Endobronchial Blockers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02133235
Other study ID # 201212175RINC
Secondary ID
Status Completed
Phase N/A
First received April 28, 2014
Last updated October 20, 2015
Start date May 2014
Est. completion date June 2015

Study information
Verified date October 2015
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.

Description:

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. However, there were previous reports showed that it takes longer time to position the EBB versus the double lumen tubes. Placing EBBs need three-step procedure (one is placing an endotracheal tube, the second is inserting the EBB, the third is confirmation of the position by fiberoptic bronchoscopy). In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional 3-step procedure, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion criteria:

Lung separation by endobronchial blockers

Exclusion criteria:

Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Procedure:
• conventional
insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
• auscultation
insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Grading for Lung Isolation A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement 10-15 minutes No
Primary Time Required for Proper Placement of the Endobronchial Blocker 10-15 minutes No
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