Trial Outcomes & Findings for EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery (NCT NCT03403192)
NCT ID: NCT03403192
Last Updated: 2021-10-07
Results Overview
Positional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
End of surgical procedure
Results posted on
2021-10-07
Participant Flow
Participant milestones
| Measure |
EZ-Blocker in the Left Lung
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
40
|
42
|
|
Overall Study
COMPLETED
|
37
|
36
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
6
|
Reasons for withdrawal
| Measure |
EZ-Blocker in the Left Lung
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Overall Study
Unable to respond
|
0
|
1
|
0
|
0
|
|
Overall Study
Incomplete
|
3
|
1
|
3
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EZ-Blocker in the Left Lung
n=41 Participants
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
n=40 Participants
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
Double Lumen Tube (DLT) in Left Lung
n=40 Participants
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
Double Lumen Tube (DLT) in Right Lung
n=42 Participants
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
65.3 years
STANDARD_DEVIATION 12.4 • n=40 Participants
|
66.2 years
STANDARD_DEVIATION 12.9 • n=40 Participants
|
60.6 years
STANDARD_DEVIATION 11.7 • n=42 Participants
|
63.5 years
STANDARD_DEVIATION 12.02 • n=163 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=41 Participants
|
19 Participants
n=40 Participants
|
15 Participants
n=40 Participants
|
22 Participants
n=42 Participants
|
76 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=41 Participants
|
21 Participants
n=40 Participants
|
25 Participants
n=40 Participants
|
20 Participants
n=42 Participants
|
87 Participants
n=163 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
41 Participants
n=41 Participants
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
42 Participants
n=42 Participants
|
163 Participants
n=163 Participants
|
|
Weight
|
81.0 kilograms
STANDARD_DEVIATION 17.1 • n=41 Participants
|
77.0 kilograms
STANDARD_DEVIATION 17.7 • n=40 Participants
|
82.9 kilograms
STANDARD_DEVIATION 16.4 • n=40 Participants
|
82.0 kilograms
STANDARD_DEVIATION 20.0 • n=42 Participants
|
80.7 kilograms
STANDARD_DEVIATION 17.8 • n=163 Participants
|
|
Body Mass Index (BMI)
|
27.8 kg/m^2
STANDARD_DEVIATION 4.8 • n=41 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=40 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.79 • n=40 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.6 • n=42 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=163 Participants
|
PRIMARY outcome
Timeframe: End of surgical procedurePositional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.
Outcome measures
| Measure |
EZ-Blocker in the Left Lung
n=41 Participants
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
n=40 Participants
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
n=40 Participants
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
n=42 Participants
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements
|
13 Number of replacements
|
14 Number of replacements
|
14 Number of replacements
|
13 Number of replacements
|
SECONDARY outcome
Timeframe: End of surgical procedureTime of placement for both devices
Outcome measures
| Measure |
EZ-Blocker in the Left Lung
n=41 Participants
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
n=40 Participants
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
n=40 Participants
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
n=42 Participants
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Time it Takes to Place for Double Lumen Tube (DLT) and EZ
|
3.2 Minutes
Interval 2.7 to 4.5
|
3.3 Minutes
Interval 2.5 to 4.9
|
2.0 Minutes
Interval 1.5 to 3.9
|
2.6 Minutes
Interval 1.3 to 3.8
|
SECONDARY outcome
Timeframe: End of surgical procedureMeasured at 1 hour intervals during operation on a scale of 1-3 with 1 being Excellent, 2 being Fair, and 3 being Poor.
Outcome measures
| Measure |
EZ-Blocker in the Left Lung
n=41 Participants
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
n=40 Participants
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
n=40 Participants
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
n=42 Participants
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Quality of Lung Isolation Between Devices
|
2.76 score on a scale
Standard Deviation 0.39
|
2.70 score on a scale
Standard Deviation 0.48
|
2.92 score on a scale
Standard Deviation 0.26
|
2.83 score on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: 2 days post operationSore throat/hoarseness postoperatively on a scale of 0-100 with 0 being No Sore Throat and 100 being Worst Sore Throat Imaginable.
Outcome measures
| Measure |
EZ-Blocker in the Left Lung
n=41 Participants
This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
EZ-Blocker in Right Lung
n=40 Participants
This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.
EZ-Blocker: The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.
|
DLT in Left Lung
n=40 Participants
This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
DLT in Right Lung
n=42 Participants
This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.
DLT: A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
|
|---|---|---|---|---|
|
Side Effects of Devices
|
0 score on a scale
Interval 0.0 to 5.0
|
3 score on a scale
Interval 0.0 to 13.0
|
5 score on a scale
Interval 0.0 to 12.0
|
0 score on a scale
Interval 0.0 to 7.0
|
Adverse Events
EZ-Blocker in the Left Lung
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EZ-Blocker in Right Lung
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DLT in Left Lung
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DLT in Right Lung
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place