Trial Outcomes & Findings for Lung Collapse With Bronchial Blocker (NCT NCT01615263)
NCT ID: NCT01615263
Last Updated: 2014-03-27
Results Overview
For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.
COMPLETED
NA
40 participants
From the beginning of one lung ventilation to 20 minutes after pleural opening
2014-03-27
Participant Flow
From April to October 1st 2012, 111 patients were assessed for inclusion criteria. 71 patients were not included and 40 were enrolled at their pre-operative visit to the thoracic surgery department.
No enrolled patient was excluded from the study prior to the randomization.
Participant milestones
| Measure |
Double Lumen Tube
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
|
Bronchial Blocker
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Double Lumen Tube
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
|
Bronchial Blocker
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Overall Study
Post-randomization exclusion
|
0
|
2
|
Baseline Characteristics
Lung Collapse With Bronchial Blocker
Baseline characteristics by cohort
| Measure |
Double Lumen Tube
n=20 Participants
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
|
Bronchial Blocker
n=20 Participants
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 18.2 • n=99 Participants
|
61.9 years
STANDARD_DEVIATION 7.5 • n=107 Participants
|
62.4 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the beginning of one lung ventilation to 20 minutes after pleural openingFor patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.
Outcome measures
| Measure |
Double Lumen Tube
n=20 Participants
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
|
Bronchial Blocker
n=18 Participants
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Time to Obtain Complete Lung Collapse
|
47.8 minutes
Standard Deviation 35.9
|
32.5 minutes
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: From pleural opening to 20 minutes afterAssessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following: 1. No lung collapse 2. Partial lung collapse, not satisfactory 3. Partial lung collapse, satisfactory 4. Complete lung collapse
Outcome measures
| Measure |
Double Lumen Tube
n=20 Participants
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
|
Bronchial Blocker
n=18 Participants
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Quality of Lung Collapse
Time 0, Partial lung collapse, not satisfactory
|
45 percentage of patients
|
17 percentage of patients
|
|
Quality of Lung Collapse
Time 0, Partial lung collapse, satisfactory
|
30 percentage of patients
|
55 percentage of patients
|
|
Quality of Lung Collapse
Time 0, Complete lung collapse
|
15 percentage of patients
|
22 percentage of patients
|
|
Quality of Lung Collapse
Time 5 min, No lung collapse
|
5 percentage of patients
|
0 percentage of patients
|
|
Quality of Lung Collapse
Time 0, No lung collapse
|
10 percentage of patients
|
6 percentage of patients
|
|
Quality of Lung Collapse
Time 5 min, Partial lung collapse not satisfactory
|
10 percentage of patients
|
6 percentage of patients
|
|
Quality of Lung Collapse
Time 5 min Partial lung collapse, satisfactory
|
65 percentage of patients
|
39 percentage of patients
|
|
Quality of Lung Collapse
Time 5 min Complete lung collapse
|
20 percentage of patients
|
55 percentage of patients
|
|
Quality of Lung Collapse
Time 10 min, No lung collapse
|
0 percentage of patients
|
0 percentage of patients
|
|
Quality of Lung Collapse
Time 10 min Partial lung collapse not satisfactory
|
10 percentage of patients
|
0 percentage of patients
|
|
Quality of Lung Collapse
Time 10 min Partial lung collapse, satisfactory
|
60 percentage of patients
|
33 percentage of patients
|
|
Quality of Lung Collapse
Time 10 min Complete lung collapse
|
30 percentage of patients
|
67 percentage of patients
|
|
Quality of Lung Collapse
Time 20 min, No lung collapse
|
0 percentage of patients
|
0 percentage of patients
|
|
Quality of Lung Collapse
Time 20 min Partial lung collapse not satisfactory
|
5 percentage of patients
|
0 percentage of patients
|
|
Quality of Lung Collapse
Time 20 min Partial lung collapse, satisfactory
|
50 percentage of patients
|
22 percentage of patients
|
|
Quality of Lung Collapse
Time 20 min Complete lung collapse
|
45 percentage of patients
|
78 percentage of patients
|
SECONDARY outcome
Timeframe: 20 minutes after pleural opening20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).
Outcome measures
| Measure |
Double Lumen Tube
n=20 Participants
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
|
Bronchial Blocker
n=18 Participants
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Opinion on the Device
|
50 percentage of right guess/opinion
|
22.2 percentage of right guess/opinion
|
SECONDARY outcome
Timeframe: Up to 5 minutes after surgeryOutcome measures
| Measure |
Double Lumen Tube
n=20 Participants
Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
|
Bronchial Blocker
n=18 Participants
Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
|
|---|---|---|
|
Use of Suction to Facilitate Lung Collapse
|
0 participants
|
1 participants
|
Adverse Events
Double Lumen Tube
Bronchial Blocker
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Jean S. Bussières, anesthesiologist, director of research
Institut universitaire de cardiologie et de pneumologie de Québec, Laval University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place