Pulsed Electromagnetic Field Therapy Compared to Conventional Mechanical Prophylaxis for Venous Thromboembolism...

BackgroundVenous thromboembolism (VTE) is frequent in patients in the intensive care unit (ICU). In patients in whom pharmacologic prophylaxis is not applicable, mechanical prophylaxis is indicated, currently with use of pneumatic compressors. In this scenario, PEMF may present as a safe and efficient option.The primary objective of the study is to compare Pulsed Electromagnetic Field Therapy (PEMF) to conventional pharmacological and/or mechanical prophylaxis for the prevention of VTE in patients in the ICU.Study designFifty patients requiring mechanical prophylaxis will be randomized to conventional mechanical VTE prophylaxis or PEMF with a device called Hyperslim^®. The primary outcomes are safety, tolerability, and device usability, using the SUS scale, a10-item questionnaire used to measure the perceived usability of a system or product. The exploratory efficacy outcome is a composite of symptomatic and asymptomatic VTE (detected by mandatory Doppler ultrasound 24-48 h after the end of mechanical prophylaxis or PEMF and on day 30 post-randomization) and death due to pulmonary embolism.DiscussionWe expect this study will provide valuable preliminary information on the safety, tolerability, device usability, and efficacy of this new method of mechanical prophylaxis for patients in the ICU who require mechanical VTE prophylaxis.