Trial Outcomes & Findings for Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices (NCT NCT03420625)

Results Overview

With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

up to one hour in total

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Hemodynamic Studies Patients undergoing different interventions to promote venous return. Washout (1 hour) in between different interventions. Patients started in different orders with: "Foot IPC", "Rapid Calf IPC", "Slow Calf IPC" and "Calf NMES".
Overall Study STARTED	10
Overall Study Baseline	10
Overall Study Foot IPC	10
Overall Study Rapid Calf IPC	10
Overall Study Slow Calf IPC	10
Overall Study Calf NMES	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemodynamic Studies n=10 Participants Patients undergoing different stimulations of venous blood flow.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 10.6 • n=10 Participants
Sex: Female, Male Female	0 Participants n=10 Participants
Sex: Female, Male Male	10 Participants n=10 Participants
Region of Enrollment Sweden	10 participants n=10 Participants

PRIMARY outcome

Timeframe: up to one hour in total

Population: The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention

With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Venous blood flow during supine position	Foot IPC n=10 Participants Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=9 Participants Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES n=10 Participants Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Blood Flow - Peak Systolic Velocity (cm/Sec)	14.1 cm/s Standard Deviation 3.42	29.5 cm/s Standard Deviation 8.4	161.6 cm/s Standard Deviation 47.8	39.0 cm/s Standard Deviation 12.5	42.1 cm/s Standard Deviation 14.9

PRIMARY outcome

Timeframe: up to one hour in total

With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Venous blood flow during supine position	Foot IPC n=10 Participants Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=9 Participants Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES n=10 Participants Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Blood Flow - Time-averaged Mean Velocity (cm/Sec)	4.58 cm/s Standard Deviation 1.18	6.53 cm/s Standard Deviation 1.29	13.24 cm/s Standard Deviation 6.35	7.12 cm/s Standard Deviation 1.33	9.18 cm/s Standard Deviation 2.30

PRIMARY outcome

Timeframe: up to one hour in total

With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Venous blood flow during supine position	Foot IPC n=10 Participants Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=9 Participants Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES n=10 Participants Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Blood Flow - Volume Flow (ml/Min)	219 ml/min Standard Deviation 104	309 ml/min Standard Deviation 132	604 ml/min Standard Deviation 303	345 ml/min Standard Deviation 124	410 ml/min Standard Deviation 184

PRIMARY outcome

Timeframe: up to one hour in total

With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Venous blood flow during supine position	Foot IPC n=10 Participants Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=9 Participants Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES n=10 Participants Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Blood Flow - Ejected Volume Per Individual Stimulus (ml)	5.5 ml Standard Deviation 3.96	9.4 ml Standard Deviation 4.0	19.8 ml Standard Deviation 8.6	60.8 ml Standard Deviation 22.2	13.6 ml Standard Deviation 5.9

SECONDARY outcome

Timeframe: one minute

Population: The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention

All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling.

Outcome measures

Outcome measures
Measure	Baseline n=10 Participants Venous blood flow during supine position	Foot IPC n=9 Participants Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 Participants Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Tolerability to IPC and NMES According to Visual Analogue Scale 0-10	6.13 units on a scale Standard Deviation 1.36	6.3 units on a scale Standard Deviation 1.17	8.0 units on a scale Standard Deviation 1.07	3.3 units on a scale Standard Deviation 1.67	—

Adverse Events

Foot IPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapid Calf IPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Slow Calf IPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Calf NMES

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Foot IPC n=10 participants at risk Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA	Rapid Calf IPC n=9 participants at risk Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA	Slow Calf IPC n=10 participants at risk Slow calf IPC: Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA	Calf NMES n=10 participants at risk Calf NMES: Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
Nervous system disorders Pain	0.00% 0/10 • 8 hours during the baseline and intervention assessments. The interventions were performed sequentially on each participant after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention. Adverse events were registered during and after the application of these interventions. Specifically assessments of pain were made during the application of each intervention.	0.00% 0/9 • 8 hours during the baseline and intervention assessments. The interventions were performed sequentially on each participant after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention. Adverse events were registered during and after the application of these interventions. Specifically assessments of pain were made during the application of each intervention.	0.00% 0/10 • 8 hours during the baseline and intervention assessments. The interventions were performed sequentially on each participant after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention. Adverse events were registered during and after the application of these interventions. Specifically assessments of pain were made during the application of each intervention.	70.0% 7/10 • Number of events 7 • 8 hours during the baseline and intervention assessments. The interventions were performed sequentially on each participant after baseline, in total 10 participants. One patient did not perform the Rapid calf IPC intervention. Adverse events were registered during and after the application of these interventions. Specifically assessments of pain were made during the application of each intervention.

Additional Information

Dr. Paul Ackermann

Karolinska University Hospital

Phone: +46 8 517 700 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place