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

Deep Vein Thrombosis Clinical Trial

Official title:

Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420625
• Other study ID #: SW2016-17-HEMOD
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.

Description:

Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• pregnancy

• previous lower limb operation involving the vascular system

• current thromboprophylactic or thrombolytic therapy

• vascular abnormalities in the lower limbs

• cardiorespiratory or renal failure causing pitting oedema

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Varicose Ulcer
• Venous Stasis
• Venous Thrombosis

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Flow - Peak Systolic Velocity (cm/Sec)	With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.	up to one hour in total
Primary	Blood Flow - Time-averaged Mean Velocity (cm/Sec)	With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.	up to one hour in total
Primary	Blood Flow - Volume Flow (ml/Min)	With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.	up to one hour in total
Primary	Blood Flow - Ejected Volume Per Individual Stimulus (ml)	With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.	up to one hour in total
Secondary	Tolerability to IPC and NMES According to Visual Analogue Scale 0-10	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.	one minute

External Links

•   Paper