An interventional study of conventional and auscultation in Neoplasms, Pulmonary and Thoracic Diseases, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-23.
Sponsored by National Taiwan University Hospital · Not applicable and Interventional
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 112 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Lung separation by endobronchial blockers
Exclusion criteria:
Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
Procedure: conventional
insertion endobronchial blocker by auscultation without conventional bronchoscopic reposition
Procedure: auscultation
insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy
Surgical Grading for Lung Isolation
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Time frame: 10-15 minutes
Time Required for Proper Placement of the Endobronchial Blocker
Time frame: 10-15 minutes
| Milestone | Conventional Fiberoptic Brochoscopy Group | Auscultation Group |
|---|---|---|
| Started | 55 | 57 |
| Completed | 55 | 57 |
| Not completed | 0 | 0 |
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
| participants | Left-sided VATS, Auscultation Group | Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Right-sided VATS, Auscultation Group | Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group |
|---|---|---|---|---|
| A: Optimal | 12 | 13 | 15 | 14 |
| B: Lung distension | 10 | 11 | 13 | 12 |
| C: Poor endobronchial blocker placement | 0 | 4 | 4 | 4 |
| seconds | Left-sided VATS, Auscultation Group | Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Right-sided VATS, Auscultation Group | Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group |
|---|---|---|---|---|
| Time Required for Proper Placement of the Endobronchial Blocker | 138.5 ± 25.5 | 130 ± 20 | 89.6 ± 9.3 | 141.1 ± 16.4 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Fiberoptic Brochoscopy Group | — | 0/55 (0%) | 0/55 (0%) |
| Auscultation Group | — | 0/57 (0%) | 3/57 (5.3%) |
| Event | Conventional Fiberoptic Brochoscopy Group | Auscultation Group |
|---|---|---|
| Failure for optimal lung isolationSurgical and medical procedures | 0/55 | 3/57 |
| Age, Categorical(Participants) | Auscultation Group | Conventional Fiberoptic Brochoscopy Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 43 | 40 | 83 |
| >=65 years | 14 | 15 | 29 |
| Age, Continuous(years) | Auscultation Group | Conventional Fiberoptic Brochoscopy Group | Total |
|---|---|---|---|
| Mean | 58 (30 to 79) | 58 (35 to 79) | 58 (30 to 79) |
| Sex: Female, Male(Participants) | Auscultation Group | Conventional Fiberoptic Brochoscopy Group | Total |
|---|---|---|---|
| Female | 30 | 20 | 50 |
| Male | 27 | 35 | 62 |
| Region of Enrollment(participants) | Auscultation Group | Conventional Fiberoptic Brochoscopy Group | Total |
|---|---|---|---|
| Taiwan | 57 | 55 | 112 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital