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Completed

NCT Number: NCT05208216

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geko device

Device

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.

Flowtron DVT

Device

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.

Primary outcomes

  1. Successful application of the intervention

    Time frame: 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 outcomes

  1. Venous return in the lower limbs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Firstkind Ltd
  • Manchester Academic Health Science Centre

Registry information

Official study title

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

Acronym: ENSARIA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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