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

NCT05208216 | Completed

• 1 other identifier: B01316
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Sepsis; Acute Illness; Venous Thromboembolism

Keywords

venous thromboembolism; Critical illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Venous return in the lower limbs

  Baseline & day 3-5.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Device: Geko device

Usual care arm

ACTIVE COMPARATOR

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

Interventions

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.

Intervention arm

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.

Usual care arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Firstkind Ltd: collaborator
• Manchester Academic Health Science Centre: collaborator

Study Sites (1)

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Related Links

• The Geko Device Homepage

MeSH Terms

Conditions

Critical Illness; Sepsis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 26, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)