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

Primary Purpose

Critical Illness, Sepsis, Acute Illness

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Geko device

Flowtron DVT

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring venous thromboembolism, Critical illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Manchester Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Usual care arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Venous return in the lower limbs

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.

Full Information

NCT ID

NCT05208216

First Posted

December 13, 2021

Last Updated

April 13, 2023

Sponsor

Manchester University NHS Foundation Trust

Collaborators

Firstkind Ltd, Manchester Academic Health Science Centre

1. Study Identification

Unique Protocol Identification Number

NCT05208216

Brief Title

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

Acronym

ENSARIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Manchester University NHS Foundation Trust

Collaborators

Firstkind Ltd, Manchester Academic Health Science Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Sepsis, Acute Illness, Venous Thromboembolism

Keywords

venous thromboembolism, Critical illness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention arm

Arm Type

Experimental

Arm Description

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

Arm Title

Usual care arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Geko device

Intervention Description

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

Intervention Name(s)

Flowtron DVT

Intervention Description

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 Outcome Measure Information:

Title

Successful application of the intervention

Description

Time Frame

Daily measurements up to day 10 after enrolment

Secondary Outcome Measure Information:

Title

Venous return in the lower limbs

Description

Time Frame

Baseline & day 3-5.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Bannard-Smith, MB ChB

Phone

01612761234

j.bannardsmith@mft.nhs.uk

Facility Information:

Facility Name

Manchester Royal Infirmary

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Bannard-Smith

Phone

01612764712

j.bannardsmith@mft.nhs.uk

First Name & Middle Initial & Last Name & Degree

Natalie Fowler, MSc

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.gekodevices.com/

Description

The Geko Device Homepage

Learn more about this trial

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

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