Comparing Pulsed Electromagnetic Field Therapy and Pneumatic Compression Devices to Prevent Blood Clots in ICU Patients

What this Trial Is About

Venous thromboembolism VTE is common in patients admitted to the intensive care unit ICU, where some cannot receive pharmacological prevention due to contraindications. This study compares Pulsed Electromagnetic Field Therapy PEMF with conventional mechanical prophylaxis for preventing VTE in ICU patients. The trial is a prospective, randomized, open-label, active-controlled study conducted at two hospitals in Brazil, focusing on patients with high VTE risk scores and specific prophylaxis needs. Participants will be randomly assigned to receive either PEMF using the Hyperslimae device or intermittent pneumatic compression with devices such as Covidien Kendall SCD 700ae or Doctor Life 2600ae. The PEMF treatment involves placing device pads on the lower limbs for 30 minutes, three times daily, while the pneumatic compression devices are applied full-time on the lower limbs during the ICU stay. Trained physiotherapists and nurses will place and monitor the devices according to institutional protocols. During the study, patients will be monitored continuously for signs of VTE, lab changes, and any local adverse effects like skin lesions or edema. Patients able to respond will rate device tolerability. VTE events will be assessed at ICU discharge and 30 days after randomization using Doppler ultrasound. The main outcome measures include the combined symptomatic and asymptomatic VTE rates at 30 days, major bleeding incidents, and device-related adverse events, with safety and efficacy analyzed statistically.

Pulsed Electromagnetic Field Therapy or Pneumatic Compression VTE Prophylaxis