Lower Limb Blood Flow Geko vs Foot Pump

NCT03317145 | Completed

• 1 other identifier: FSK-FP-001
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this pilot study was to assess venous flow parameters in patients following total hip arthroplasty, comparing an intermittent pneumatic compression foot device with a portable neuromuscular electrostimulator device. Assessments were performed in a single sitting before hospital discharge, between days 1 to 4 post operatively. The total duration of participation for each patient who completed the study was approximately 2.5 hours.

Conditions

Venous Thrombosis; Arthroplasty, Replacement, Hip

Keywords

venous thromboembolism; deep vein thrombosis; pulmonary embolism; neuromuscular electrostimulation; foot compression; hip replacement

Outcome Measures

Primary Outcomes (3)

• Venous flow at baseline

  Measured within the superficial femoral vein using ultrasound

  "t0" - 30 minutes to include the ultrasound assessment, performed between days 1 and 4 post operatively

• Venous flow after application of device 1

  Measured within the superficial femoral vein using ultrasound

  "t1" - 90 minutes to include the ultrasound assessment

• Venous flow after application of device 2

  Measured within the superficial femoral vein using ultrasound

  "t2" - 150 minutes to include the ultrasound assessment

Secondary Outcomes (2)

• Patient satisfaction with device 1

  Immediately after completion of the ultrasound assessment for device 1, at "t1" - 90 minutes

• Patient satisfaction with device 2

  Immediately after completion of the ultrasound assessment for device 2, at "t2" - 150 minutes

Study Arms (2)

Arm A (NMES followed by IPC)

ACTIVE COMPARATOR

Arm A (NMES followed by IPC). Following baseline blood flow measurements using ultrasound, the neuromuscular electrostimulation (NMES) device will be fitted and allowed to operate for 10 minutes. Blood flow measurements will then be repeated. The NMES device will be removed. After a 30 minute rest period, the intermittent pneumatic compression (IPC) device will be fitted, activated for 10 minutes and then blood flow measurements repeated.

Device: Neuromuscular electrostimulation (NMES) device; Device: Intermittent pneumatic compression (IPC) device

Arm B (IPC followed by NMES)

ACTIVE COMPARATOR

Arm B (IPC followed by NMES). Following baseline blood flow measurements using ultrasound, the intermittent pneumatic compression device (IPC) will be fitted and allowed to operate for 10 minutes. Blood flow measurements will then be repeated. The IPC device will be removed. After a 30 minute rest period, the neuromuscular electrostimulation (NMES) device will then be fitted, activated for 10 minutes and then blood flow measurements repeated

Device: Neuromuscular electrostimulation (NMES) device; Device: Intermittent pneumatic compression (IPC) device

Interventions

Neuromuscular electrostimulation (NMES) device DEVICE

A mobile peroneal nerve stimulator

Also known as: Geko T-1

Arm A (NMES followed by IPC); Arm B (IPC followed by NMES)

Intermittent pneumatic compression (IPC) device DEVICE

A foot pump or foot compression device

Also known as: Vadoplex

Arm A (NMES followed by IPC); Arm B (IPC followed by NMES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing primary THA,
• in good general health and fitness,
• age 18 years or over
• able to provide written informed consent.

You may not qualify if:

• Are requiring hip revision surgery
• Previous or current diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
• History or signs of significant haematological disorders (especially in relation to clotting or coagulation) or thrombophlebitis.
• Peripheral arterial disease, clinically significant varicose veins or lower limb ulceration or ischemia.
• Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
• Recent trauma to lower limb.
• Chronic Obesity (BMI Index \>40kg/m2).
• Pregnancy.
• Significant history of following diseases i. Cardiovascular: Recent MI (\< 6 months) ii. Percutaneous Coronary Intervention (PCI) with stent (\< 3 months for Bare metal stent (BMS) and \< 12 months for Drug Eluding Stent (DES) iii. Moderate to severe CCF, uncontrolled AF iv. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies v. Renal: Moderate to severely impaired renal function vi. Hepatic: Moderate to severely impaired hepatic function vii. Psychiatric disorders viii. Dermatological conditions affecting lower limbs
• On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
• Long term steroid use with dermatological changes
• A pulse rate of less than 40 beats/minute
• A sitting systolic blood pressure \>180 and \<100 mmHg and/or a sitting diastolic pressure of \>100 mmHg.
• Participation in any clinical study during the eight (8) weeks preceding the screening period
• THR done for hip fracture

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead
• Firstkind Ltd: collaborator

Related Publications (2)

• Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.

  PMID: 23999610 BACKGROUND

• Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.

  PMID: 24722790 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Geoff Stranks, FRCS

  North Hampshire Hospital, Basingstoke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who have had a total hip replacement will be randomised to wear either a foot compression (IPC) device or a neuromuscular electrostimulation (NMES) device (gekoTM) first. Blood flow will be measured using both devices on the same patient in sequence. The blood flow measurements will be done by ultrasound. Each ultrasound assessment will take approximately 30 minutes in total. Baseline blood flow measurements will be taken initially. The first device will then be fitted and allowed to operate for 10 minutes before ultrasound measurements are taken. After a rest period of 30 minutes, the second device is then fitted and allowed to operate for 10 minutes, following which blood flow measurements are repeated. Patients will then be asked to complete a questionnaire to assess the comfort of each device.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 23, 2017
• Study Start: July 24, 2013
• Primary Completion: February 19, 2014
• Study Completion: February 19, 2014
• Last Updated: September 21, 2021

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share