Trial Outcomes & Findings for The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker (NCT NCT02133235)
NCT ID: NCT02133235
Last Updated: 2015-11-23
Results Overview
A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
10-15 minutes
Results posted on
2015-11-23
Participant Flow
Participant milestones
| Measure |
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
|
Auscultation Group
patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
57
|
|
Overall Study
COMPLETED
|
55
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker
Baseline characteristics by cohort
| Measure |
Auscultation Group
n=57 Participants
patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
|
Conventional Fiberoptic Brochoscopy Group
n=55 Participants
patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Age, Continuous
|
58 years
n=93 Participants
|
58 years
n=4 Participants
|
58 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
57 participants
n=93 Participants
|
55 participants
n=4 Participants
|
112 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10-15 minutesA: Optimal; B: Lung distension; C: Poor endobronchial blocker placement
Outcome measures
| Measure |
Left-sided VATS, Auscultation Group
n=22 Participants
patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
|
Left-sided VATS, Conventional Fiberoptic Brochoscopy Group
n=28 Participants
patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
|
Right-sided VATS, Auscultation Group
n=32 Participants
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
|
Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group
n=30 Participants
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
|
|---|---|---|---|---|
|
Surgical Grading for Lung Isolation
A: Optimal
|
12 participants
|
13 participants
|
15 participants
|
14 participants
|
|
Surgical Grading for Lung Isolation
B: Lung distension
|
10 participants
|
11 participants
|
13 participants
|
12 participants
|
|
Surgical Grading for Lung Isolation
C: Poor endobronchial blocker placement
|
0 participants
|
4 participants
|
4 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 10-15 minutesOutcome measures
| Measure |
Left-sided VATS, Auscultation Group
n=25 Participants
patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
|
Left-sided VATS, Conventional Fiberoptic Brochoscopy Group
n=25 Participants
patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
|
Right-sided VATS, Auscultation Group
n=32 Participants
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
|
Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group
n=30 Participants
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
|
|---|---|---|---|---|
|
Time Required for Proper Placement of the Endobronchial Blocker
|
138.5 seconds
Standard Deviation 25.5
|
130 seconds
Standard Deviation 20
|
89.6 seconds
Standard Deviation 9.3
|
141.1 seconds
Standard Deviation 16.4
|
Adverse Events
Conventional Fiberoptic Brochoscopy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Auscultation Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Fiberoptic Brochoscopy Group
n=55 participants at risk
patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
|
Auscultation Group
n=57 participants at risk
patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
|
|---|---|---|
|
Surgical and medical procedures
Failure for optimal lung isolation
|
0.00%
0/55 • 1 week
|
5.3%
3/57 • Number of events 3 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place