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

NHS Foundation Trust

Status: Completed

Conditions: Venous Thromboembolism; Critical Illness; Acute Illness; Sepsis

Treatments: Device: Flowtron DVT; Device: Geko device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05208216

B01316

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Application of the Geko device for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).

Treatment:

Device: Geko device

Usual care arm

Active Comparator group

Description:

Application of our usual intermittent pneumatic compression devices for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).

Treatment:

Device: Flowtron DVT