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

Not Applicable

Recruiting

• Conditions: Critical Illness; Acute Illness; Sepsis; Venous Thromboembolism
• Interventions: Device: Geko device; Device: Flowtron DVT

• Registration Number: NCT05208216
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Study Start: 2022-11-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Geko device	Application of the Geko device for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).
Usual care arm	Flowtron DVT	Application of our usual intermittent pneumatic compression devices for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).

Primary Outcome Measures

Name	Time	Method
Successful application of the intervention	Daily measurements up to day 10 after enrolment	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.

Secondary Outcome Measures

Name	Time	Method
Venous return in the lower limbs	Baseline & day 3-5.	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.

Trial Locations

Locations (1)

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom