Neoplasms, Pulmonary, Thoracic Diseases
Conditions
Keywords
endobronchial blocker, lung separation, vedio-assisted thoracic operation
Brief 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.
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.
Interventions
PROCEDUREconventional
insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
PROCEDUREauscultation
insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Lung separation by endobronchial blockers
Exclusion criteria
Lung separation by conventional double lumen tube Lung separation with endobronchial blockers through
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Grading for Lung Isolation | 10-15 minutes | A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement |
| Time Required for Proper Placement of the Endobronchial Blocker | 10-15 minutes | — |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auscultation Group patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition | 57 |
| 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 | 55 |
| Total | 112 |
Baseline characteristics
| Characteristic | Conventional Fiberoptic Brochoscopy Group | Auscultation Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 43 Participants | 83 Participants |
| Age, Continuous | 58 years | 58 years | 58 years |
| Region of Enrollment Taiwan | 55 participants | 57 participants | 112 participants |
| Sex: Female, Male Female | 20 Participants | 30 Participants | 50 Participants |
| Sex: Female, Male Male | 35 Participants | 27 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 3 / 57 |
| serious Total, serious adverse events | 0 / 55 | 0 / 57 |
Outcome results
Primary
Surgical Grading for Lung Isolation
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Time frame: 10-15 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Left-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | C: Poor endobronchial blocker placement | 0 participants |
| Left-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | B: Lung distension | 10 participants |
| Left-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | A: Optimal | 12 participants |
| Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Surgical Grading for Lung Isolation | C: Poor endobronchial blocker placement | 4 participants |
| Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Surgical Grading for Lung Isolation | A: Optimal | 13 participants |
| Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Surgical Grading for Lung Isolation | B: Lung distension | 11 participants |
| Right-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | A: Optimal | 15 participants |
| Right-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | B: Lung distension | 13 participants |
| Right-sided VATS, Auscultation Group | Surgical Grading for Lung Isolation | C: Poor endobronchial blocker placement | 4 participants |
| Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group | Surgical Grading for Lung Isolation | C: Poor endobronchial blocker placement | 4 participants |
| Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group | Surgical Grading for Lung Isolation | B: Lung distension | 12 participants |
| Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group | Surgical Grading for Lung Isolation | A: Optimal | 14 participants |
Primary
Time Required for Proper Placement of the Endobronchial Blocker
Time frame: 10-15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Left-sided VATS, Auscultation Group | Time Required for Proper Placement of the Endobronchial Blocker | 138.5 seconds | Standard Deviation 25.5 |
| Left-sided VATS, Conventional Fiberoptic Brochoscopy Group | Time Required for Proper Placement of the Endobronchial Blocker | 130 seconds | Standard Deviation 20 |
| Right-sided VATS, Auscultation Group | Time Required for Proper Placement of the Endobronchial Blocker | 89.6 seconds | Standard Deviation 9.3 |
| Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group | Time Required for Proper Placement of the Endobronchial Blocker | 141.1 seconds | Standard Deviation 16.4 |