Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study

What this Trial Is About

Acute compartment syndrome ACS is a serious surgical emergency that can occur in patients receiving extracorporeal membrane oxygenation ECMO, especially veno-arterial VA ECMO. ACS happens when increased pressure in a muscle compartment reduces blood flow, leading to limb damage. Diagnosing ACS in ECMO patients is difficult because they are usually sedated and cannot report symptoms like pain. This study evaluates and compares three methods to diagnose ACS the current standard of care, the new MY01 Continuous Compartment Pressure Monitor device alongside standard care, and a 14-gauge slit catheter device with standard care, aiming to improve accuracy and early detection. Participants will be randomly assigned to one of three groups. The standard care group involves physical exams every 4 hours and single pressure needle measurements if ACS is suspected. The MY01 group will have the device inserted into the leg near the ECMO tubing to continuously monitor pressures for 24 hours, with data accessible via a mobile app. The 14-gauge slit catheter group will use tubing inserted into the leg, connected to a monitor with pressure readings recorded every 4 hours for 24 hours. If ACS is diagnosed, surgery decisions will be made by the medical team. The device is removed after monitoring or upon diagnosis. During the study, participants will undergo regular physical exams and pressure monitoring according to their assigned group. Researchers will track the number of patients diagnosed with ACS, those needing amputation, deaths during hospitalization, and amputation-free survival, with follow-up lasting up to one year. Monitoring will include continuous or intermittent pressure measurements and clinical assessments. The study will help assess the effectiveness of continuous pressure monitoring devices compared to standard care in detecting ACS and potentially improving treatment timing and limb outcomes.

Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients