Trial Outcomes & Findings for A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices (NCT NCT02345642)
NCT ID: NCT02345642
Last Updated: 2017-10-16
Results Overview
Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied
Results posted on
2017-10-16
Participant Flow
Participant milestones
| Measure |
10 Healthy Patients Without THA
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them. A randomization technique was used to determine laterality and sequence of study events.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
10 Patients With THA on Post-Op Day 2
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Hemodynamic Comparison of Stationary and Portable Pneumatic Compression Devices
Baseline characteristics by cohort
| Measure |
10 Healthy Patients Without THA
n=10 Participants
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
10 Patients With THA on Post-Op Day 2
n=10 Participants
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
28.7 years
n=5 Participants
|
64.6 years
n=7 Participants
|
46.65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in Peak Venous Velocity 30 minutes after Device is AppliedUltrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.
Outcome measures
| Measure |
10 Healthy Patients Without THA
n=10 Participants
The 10 test subjects of this study arm will be healthy volunteers of various ages that are willing to have the efficacy of pneumatic compression tested on them.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
10 Patients With THA on Post-Op Day 2
n=10 Participants
The 10 test subjects of this study arm will be primary THR patients of Dr. Westrich that have undergone uncomplicated THR surgery in which they are allowed to be full weight bearing by or before post-op day 2.
ActiveCare+SFT Supine
VenaFlow Elite Supine
ActiveCare+SFT Standing
VenaFlow Elite Standing
|
|---|---|---|
|
Peak Venous Velocity
delta PVV from before to after Activecare (supine)
|
40.5 cm/s
Interval 9.0 to 66.0
|
37.8 cm/s
Interval 28.0 to 51.0
|
|
Peak Venous Velocity
Delta PVV from before to after Venaflow (Standing)
|
127.9 cm/s
Interval 40.0 to 188.0
|
155.7 cm/s
Interval 106.0 to 270.0
|
|
Peak Venous Velocity
Delta PVV from before to after Venaflow (Supine)
|
87.1 cm/s
Interval 51.0 to 204.0
|
86.8 cm/s
Interval 26.0 to 165.0
|
|
Peak Venous Velocity
delta PVV from before to after Activeca (Standing)
|
32.6 cm/s
Interval 16.0 to 44.0
|
41.9 cm/s
Interval 11.0 to 85.0
|
Adverse Events
10 Patients With THA on Post-Op Day 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 Healthy Patients Without THA
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