MedDataX Logo

The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker

NCT ID: NCT02133235

Last Updated: 2015-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Pulmonary Thoracic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional

insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition

Group Type ACTIVE_COMPARATOR

conventional

Intervention Type PROCEDURE

insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy

auscultation

insertion endobronchial blocker by auscultation without conventional bronchoscopic reposition

Group Type EXPERIMENTAL

auscultation

Intervention Type PROCEDURE

insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

conventional

insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy

Intervention Type PROCEDURE

auscultation

insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Lung separation by endobronchial blockers

Exclusion Criteria

Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ya-Jung Cheng

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28950380 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201212175RINC

Identifier Type: -

Identifier Source: org_study_id