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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peripheral Vascular Disease and Nerve Stimulation

NCT01942941

Critical Limb Ischaemia Claudication Ulcers +2 more

COMPLETED NA

Study of gekoTM Interaction With Cardiac Pacemakers

NCT04391257

Stroke Wound Heal Edema Leg +1 more

COMPLETED NA

Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.

NCT06135857

Thrombosis; Catheter, Infusion Catheter (Vascular)

NOT_YET_RECRUITING NA

A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

NCT02884323

Venous Leg Ulcer

COMPLETED NA

Improving Lower Limb Blood Flow in Healthy Adult Volunteers

NCT01981733

Deep Vein Thrombosis

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Sepsis Acute Illness Venous Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

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

Group Type EXPERIMENTAL

Geko device

Intervention Type 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.

Usual care arm

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

Group Type ACTIVE_COMPARATOR

Flowtron DVT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Geko 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 Type DEVICE

Flowtron DVT

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No