Trial Outcomes & Findings for Powered Echelon Device in VATS Surgery (NCT NCT01843192)
NCT ID: NCT01843192
Last Updated: 2015-06-18
Results Overview
Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
COMPLETED
71 participants
Post-operative period through hospital discharge and follow-up at Day 30
2015-06-18
Participant Flow
Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.
There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.
Participant milestones
| Measure |
Wedge Resection
Subjects undergoing VATS wedge resection
|
Lobectomy
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
34
|
11
|
|
Overall Study
COMPLETED
|
24
|
28
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
2
|
Reasons for withdrawal
| Measure |
Wedge Resection
Subjects undergoing VATS wedge resection
|
Lobectomy
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Overall Study
Intra-operative exclusions per protocol
|
2
|
6
|
2
|
Baseline Characteristics
Powered Echelon Device in VATS Surgery
Baseline characteristics by cohort
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 7.26 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 5.72 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 8.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
9 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Occurrence of Postoperative Air Leaks
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
PRIMARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Occurrence of Prolonged Air Leaks
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
SECONDARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Determined as the length of time in days from hospital admission to initial hospital discharge
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Length of Stay (LOS)
|
3.7 days
Standard Deviation 1.63
|
4.9 days
Standard Deviation 1.70
|
4.8 days
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Blood loss intra-op and up to 5 days post-opPopulation: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Volume of Estimated Intra-operative Blood Loss
|
31.5 milliliters
Standard Deviation 56.48
|
83.2 milliliters
Standard Deviation 62.42
|
86.1 milliliters
Standard Deviation 80.15
|
SECONDARY outcome
Timeframe: Post-operative period through hospital discharge and follow-up at Day 30Population: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Time to Chest Tube Removal
|
3.7 days
Standard Deviation 1.63
|
4.9 days
Standard Deviation 1.7
|
4.8 days
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
Defined as the duration in hours from the first skin incision to the closure of the last incision
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Operative Time
|
1.7 hours
Standard Deviation 0.68
|
2.8 hours
Standard Deviation 0.85
|
3.4 hours
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: During surgeryPopulation: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.
This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.
Outcome measures
| Measure |
Wedge Resection
n=2 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=12 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=3 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Occurrence of Intra-operative Leak Test
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: During surgeryPopulation: All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure
All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.
Outcome measures
| Measure |
Wedge Resection
n=24 Participants
Subjects undergoing VATS wedge resection
|
Lobectomy
n=28 Participants
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=9 Participants
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Number of Subjects With 1 Chest Tube Placed
|
88.5 percentage of participants
|
100 percentage of participants
|
88.9 percentage of participants
|
Adverse Events
Wedge Resection
Lobectomy
Wedge Resection With Lobectomy
Serious adverse events
| Measure |
Wedge Resection
n=26 participants at risk
Subjects undergoing VATS wedge resection
|
Lobectomy
n=34 participants at risk
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=11 participants at risk
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
3.8%
1/26 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
3.8%
1/26 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
18.2%
2/11 • Number of events 2 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Number of events 1 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
Other adverse events
| Measure |
Wedge Resection
n=26 participants at risk
Subjects undergoing VATS wedge resection
|
Lobectomy
n=34 participants at risk
Subjects undergoing VATS lobectomy
|
Wedge Resection With Lobectomy
n=11 participants at risk
Subjects undergoing VATS wedge resection that also required lobectomy
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
5.9%
2/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
18.2%
2/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
5.9%
2/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Infections and infestations
Cellulitis
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
2.9%
1/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Cardiac disorders
Supraventricular extrasystoles
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
9.1%
1/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
9.1%
1/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Renal and urinary disorders
Renal cyst
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/34 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
0.00%
0/11 • Duration of follow-up was scheduled through approximately 4 weeks post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60