The ENSARIA Trial
Research type
Research Study
Full title
Electronic Neuromuscular Stimulation versus Intermittent Pneumatic Compression Devices for the Prevention of Venous Thromboembolic Disease in Critically Ill Adults: a randomised feasibility study.
IRAS ID
284315
Contact name
Jonathan Bannard-Smith
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Blood clots in the veins are a life threatening medical condition which can affect up to 1 in 3 patients admitted to critical care. Standard practice to reduce the risk of blood clots involves using compression stockings or compression devices. Compression stockings are not suitable for patients with diseases affecting the blood vessels, making them unsuitable for many critical care patients. Compression devices are made up of single use leg wraps/boots that are connected to a mains unit which intermittently squeeze the patient’s leg. These devices are bulky, difficult to clean and are not well tolerated by patients.
This research will evaluate an innovative device compared to standard care on the Critical Care Unit at Manchester Royal Infirmary. The Geko device is a small battery powered disc that sticks to the patient’s knee and electrically stimulates contraction of the calf muscles. It has a CE mark for use in hospitlised patientc, but not yet formally evaluated in critical care. This single-center study will enrol 40 patients who will be randomised to receive standard compression devices or the Geko device. Patients will be followed up daily until day-10, and at day-90. Additional assessments will include lower limb ultrasound to identify venous thromboembolic disease.
The primary objective of this study is to prove feasibility in recrutiment and application of the Geko device, prior to planning a future efficacy trial. This study will measure outcomes relevant to the development of blood clots, from limb ultrasounds and vital signs data, to understand how the Geko works. It will also look at the carbon cost of the Geko compared to standard practice and the cost effectiveness.
This study is co-funded between our local academic health sciences network and the device manufacturer.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0098
Date of REC Opinion
19 Jul 2022
REC opinion
Further Information Favourable Opinion