Neoplasms, PulmonaryNCT02133235

The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker

A study testing conventional and auscultation in people with Neoplasms, Pulmonary and Thoracic Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Neoplasms, Pulmonary, Thoracic Diseases
What is being tested?: conventional and auscultation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteTaiwan
Study dates: May 2014to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Lung separation by endobronchial blockers

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taiwan University Hospital
Taipei, Taiwan, 100

Other trials in Taiwan

About this study

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

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.

Read the detailed 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.

Conditions: Neoplasms, Pulmonary, Thoracic Diseases
Being tested: conventional, auscultation
Keywords: endobronchial blocker, lung separation, vedio-assisted thoracic operation
Medical subject headings: Lung Neoplasms, Thoracic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

conventionalProcedure or surgery
insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
auscultationProcedure or surgery
insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy

Study groups in NCT02133235
Study group	Role	What they receive
conventional	Active comparator	insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition Receives: Procedure: conventional
auscultation	Experimental	insertion endobronchial blocker by auscultation without conventional bronchoscopic reposition Receives: Procedure: auscultation

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical Grading for Lung Isolation
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Measured: 10-15 minutes
Time Required for Proper Placement of the Endobronchial Blocker
Measured: 10-15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2015

First posted7 May 2014 (estimated)
Study startMay 2014
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoplasms, PulmonaryStudies of the same condition, open and under way.
More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02133235
Sponsor's protocol ID: 201212175RINC
Status last verified: Oct 2015
First submitted: 28 Apr 2014
Last updated: 23 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28950380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Need and the Effectiveness of Fiberoptic Bronchoscopy for Better Lung Collapse in Vedio-assisted Thoracic Operations Using Endobronchial Blockers
ClinicalTrials.gov ID: NCT02133235
Acronym / sponsor ID: 201212175RINC
Conditions: Neoplasms, Pulmonary, Thoracic Diseases
Keywords: endobronchial blocker, lung separation, vedio-assisted thoracic operation
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Study start: May 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 23 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
conventional	Active comparator	Procedure: conventionalinsertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
auscultation	Experimental	Procedure: auscultationinsertion endobronchial blocker by auscultation without conventional bronchoscopic reposition

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Lung separation by endobronchial blockers

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
conventionalinsertion endobronchial blocker with the guidance of fiberoptic bronchoscopy	Procedure or surgery	conventional
auscultationinsertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy	Procedure or surgery	auscultation

Primary outcome

Surgical Grading for Lung Isolation
Time frame: 10-15 minutes
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Time Required for Proper Placement of the Endobronchial Blocker
Time frame: 10-15 minutes

Results and safety

Results posted to the registry on 23 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Fiberoptic Brochoscopy Group	55	55
Auscultation Group	57	57

Primary outcome: Surgical Grading for Lung Isolation

Time frame: 10-15 minutes. Number. Unit: participants

Measure	Left-sided VATS, Auscultation Group n = 22	Left-sided VATS, Conventional Fiberoptic Brochoscopy Group n = 28	Right-sided VATS, Auscultation Group n = 32	Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group n = 30
A: Optimal	12	13	15	14
B: Lung distension	10	11	13	12
C: Poor endobronchial blocker placement	0	4	4	4

Primary outcome: Time Required for Proper Placement of the Endobronchial Blocker

Time frame: 10-15 minutes. Mean (Standard Deviation). Unit: seconds

Measure	Left-sided VATS, Auscultation Group n = 25	Left-sided VATS, Conventional Fiberoptic Brochoscopy Group n = 25	Right-sided VATS, Auscultation Group n = 32	Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group n = 30
Value	138.5 (25.5)	130 (20)	89.6 (9.3)	141.1 (16.4)

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Fiberoptic Brochoscopy Group	0 of 55 (0%)	0 of 55 (0%)	Not reported
Auscultation Group	0 of 57 (0%)	3 of 57 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28950380Wang 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.

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ya-Jung Cheng principal investigator

National Taiwan University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing conventional and auscultation in people with Neoplasms, Pulmonary and Thoracic Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Grading for Lung Isolation (time frame: 10-15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.