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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional | Active Comparator | insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition |
|
| auscultation | Experimental | insertion endobronchial blocker by auscultation without conventional bronchoscopic reposition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional | Procedure | insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Lung separation by endobronchial blockers
Exclusion criteria:
Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
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| Name | Affiliation | Role |
|---|---|---|
| Ya-Jung Cheng | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28950380 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Fiberoptic Brochoscopy Group | patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition |
| FG001 | Auscultation Group | patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Auscultation Group | patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition |
| BG001 | Conventional Fiberoptic Brochoscopy Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgical Grading for Lung Isolation | A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement | Posted | Number | participants | 10-15 minutes |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Fiberoptic Brochoscopy Group | patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure for optimal lung isolation | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YJ Cheng | NTUH | 886-2-23123456 | 62158 | chengyj@ntu.edu.tw |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| D001307 | Auditory Perception |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
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| auscultation | Procedure | insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy |
|
patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Right-sided VATS, Auscultation Group | patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only |
| OG003 | Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group | patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group |
|
|
| Primary | Time Required for Proper Placement of the Endobronchial Blocker | Posted | Mean | Standard Deviation | seconds | 10-15 minutes |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Auscultation Group | patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition | 0 | 57 | 3 | 57 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |