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

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208216
• Other study ID #: B01316
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Jonathan Bannard-Smith, MB ChB
• Phone: 01612761234
• Email: j.bannardsmith[@]mft.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Illness
• Critical Illness
• Sepsis
• Thromboembolism
• Venous Thromboembolism

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Firstkind Ltd, Manchester Academic Health Science Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline & day 3-5.

External Links

•   The Geko Device Homepage