Acute Illness, Critical Illness, Sepsis, Venous Thromboembolism
Conditions
Keywords
venous thromboembolism, Critical illness
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.
Interventions
DEVICEGeko 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.
DEVICEFlowtron 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.
Sponsors
Firstkind Ltd
Manchester Academic Health Science Centre
Manchester University NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful application of the intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Venous return in the lower limbs | 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. |
Countries
United Kingdom
Outcome results
None listed