Neuromuscular Stimulation Versus Intermittent Compression for Venous Thromboembolism Prophylaxis in Critical Care

Study Overview
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Brief Summary
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In this prospective, randomised, open-label, parallel group, feasibility trial; the investigators will objectively assess whether it is feasible to apply the Geko device to critically ill adults for the prevention of venous thromboembolism (VTE) compared to usual care with intermittent pneumatic compression devices (IPCs).

Detailed Description
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VTE is a common problem amongst patients in critical care. Current measures include intermittent pneumatic compression devices, used to aid the venous return of blood from the lower limbs. These devices are contraindicated and/or poorly tolerated by some patients. Neuromuscular stimulation of the lower leg muscles might offer a better tolerated and more physiological alternative to IPCs. In this feasibility trial the investigators will randomly allocate 40 patients to receive either the Geko device (n=20) or IPCs (n=20) as principal means of mechanical VTE prophylaxis.

Official Title
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Electronic Neuromuscular Stimulation Versus Intermittent pneumAtic Compression Devices for the pRevention of Venous Thromboembolic Disease in Critically Ill Adults: a Randomised Feasibility Study

Conditions
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Sepsis, Critical Illness, Acute Illness, Venous Thromboembolism

Intervention / Treatment
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* Device: Geko device
* Device: Flowtron DVT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥ 18 years. Intact healthy skin at the proposed site of gekoTM device application. Within 24 hours of their admission to critical care Expected to remain in critical care until the day after tomorrow Exclusion Criteria: Use of any concurrent neuro-modulation drug or device (e.g. neuromuscular blocking agents). Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. Inability to palpate the fibula head in order to apply geko device effectively Inability to obtain valid written consent from the participant or their designated legal representative

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Application of the Geko device for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner). | Device: Geko device<br>* A small battery powered device that provides neuromuscular stimulation to the muscles of the lower leg to enhance venous return from the leg and reduce the risk of patient developing VTE.<br>|
| Active Comparator: Usual care arm<br>Application of our usual intermittent pneumatic compression devices for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner). | Device: Flowtron DVT<br>* A pneumatically powered pair of calf boots device that intermittently compress the muscles of the lower leg to enhance venous return from the leg and reduce the risk of patient developing VTE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful application of the intervention | Objective measures of feasibility will include successful application of the intervention device. Investigators will make a daily assessment of whether the device is successfully applied to a participant or not. Successful application is defined as a device applied and producing a visible muscle twitch in the participant's lower leg. A predefined threshold of 70% or above would indicate feasibility of effective application of the intervention to trial participants. | Daily measurements up to day 10 after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous return in the lower limbs | Objective measurements of blood velocity in the femoral veins will be made through expert bedside ultrasound scans on participant's lower limbs. Two assessments of this outcome will be made, one at baseline prior to application of any device and another between days 3-5. | Baseline & day 3-5. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous thromboembolism, Critical illness