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Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices

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ClinicalTrials.gov Identifier: NCT03420625
Recruitment Status : Completed
First Posted : February 2, 2018
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Ackermann, Karolinska University Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Venous Stasis
Deep Vein Thrombosis
Interventions Device: Foot IPC
Device: Rapid calf IPC
Device: Slow calf IPC
Device: Calf NMES
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hemodynamic Studies
Hide Arm/Group Description 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".
Period Title: Overall Study
Started 10
Baseline [1] 10
Foot IPC [2] 10
Rapid Calf IPC [3] 10
Slow Calf IPC [4] 10
Calf NMES [5] 10
Completed 10
Not Completed 0
[1]
Venous flow in the popliteal vein during supine position
[2]
Intermittent pneumatic compression of the foot using A-V Impulse™, Covidien®, New Haven, CT, USA
[3]
Intermittent pneumatic compression of the calf using the VenaFlow® Elite, DJO Global, USA
[4]
Intermittent pneumatic compression of the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
[5]
Neuromuscular electrical stimulation of the calf using the CefarCompex Mi-Theta 500 stimulator
Arm/Group Title Hemodynamic Studies
Hide Arm/Group Description Patients undergoing different stimulations of venous blood flow.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
39.7  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 10 participants
10
1.Primary Outcome
Title Blood Flow - Peak Systolic Velocity (cm/Sec)
Hide Description With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
Time Frame up to one hour in total
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Baseline Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description:
Venous blood flow during supine position

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

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

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

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

Overall Number of Participants Analyzed 10 10 9 10 10
Mean (Standard Deviation)
Unit of Measure: cm/s
14.1  (3.42) 29.5  (8.4) 161.6  (47.8) 39.0  (12.5) 42.1  (14.9)
2.Primary Outcome
Title Blood Flow - Time-averaged Mean Velocity (cm/Sec)
Hide Description With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
Time Frame up to one hour in total
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description:
Blood flow during supine position

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

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

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

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

Overall Number of Participants Analyzed 10 10 9 10 10
Mean (Standard Deviation)
Unit of Measure: cm/s
4.58  (1.18) 6.53  (1.29) 13.24  (6.35) 7.12  (1.33) 9.18  (2.30)
3.Primary Outcome
Title Blood Flow - Volume Flow (ml/Min)
Hide Description With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
Time Frame up to one hour in total
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description:
Blood flow during supine position

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

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

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

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

Overall Number of Participants Analyzed 10 10 9 10 10
Median (Standard Deviation)
Unit of Measure: ml/min
219  (104) 309  (132) 604  (303) 345  (124) 410  (184)
4.Primary Outcome
Title Blood Flow - Ejected Volume Per Individual Stimulus (ml)
Hide Description With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
Time Frame up to one hour in total
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description:
Blood flow during supine position

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

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

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

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

Overall Number of Participants Analyzed 10 10 9 10 10
Mean (Standard Deviation)
Unit of Measure: ml
5.5  (3.96) 9.4  (4.0) 19.8  (8.6) 60.8  (22.2) 13.6  (5.9)
5.Secondary Outcome
Title Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
Hide Description 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.
Time Frame one minute
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 10 9 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.13  (1.36) 6.3  (1.17) 8.0  (1.07) 3.3  (1.67)
Time Frame 8 hours during the baseline and intervention assessments.
Adverse Event Reporting Description

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.

 
Arm/Group Title Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Hide Arm/Group Description Foot IPC: Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Rapid calf IPC: Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, 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 DJOTM, CefarCompex Mi-Theta 500 stimulator
All-Cause Mortality
Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/9 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Foot IPC Rapid Calf IPC Slow Calf IPC Calf NMES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      0/10 (0.00%)      7/10 (70.00%)    
Nervous system disorders         
Pain  1 [1]  0/10 (0.00%)  0 0/9 (0.00%)  0 0/10 (0.00%)  0 7/10 (70.00%)  7
1
Term from vocabulary, Pain
Indicates events were collected by systematic assessment
[1]
Pain in the limb with cramping sensation when applying NMES. Comfortability scale (0-10). When patients scored 4 or less.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paul Ackermann
Organization: Karolinska University Hospital
Phone: +46 8 517 700 00 ext 717 34
Responsible Party: Paul Ackermann, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03420625     History of Changes
Other Study ID Numbers: SW2016-17-HEMOD
First Submitted: February 8, 2017
First Posted: February 2, 2018
Results First Submitted: August 7, 2018
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019