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

Launched by JOHNS HOPKINS UNIVERSITY · Apr 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose a serious condition called acute compartment syndrome (ACS) in patients who are on a heart-lung machine known as extracorporeal membrane oxygenation (ECMO). ACS can happen when blood flow to a limb, usually a leg, is restricted, leading to severe pain and potential loss of function. Because patients on ECMO are often sedated and unable to communicate their symptoms, it can be challenging for doctors to recognize ACS. This trial is testing a new device, the MY01 Continuous Compartment Pressure Monitor, which provides continuous pressure readings in the limb, compared to the usual method that only gives a single measurement. This could lead to quicker diagnosis and treatment, potentially saving more limbs.

To participate in this study, individuals must be adults aged 18 or older who are receiving ECMO and are sedated. However, those with pre-existing limb issues or severe trauma that prevents the use of the device, as well as patients with very poor survival chances, will not be eligible. If you join this trial, you can expect to be monitored closely, and your doctors will use either the standard method or the new MY01 device to help determine if you have ACS. This research aims to improve the way doctors diagnose this urgent condition, ultimately benefiting patients who face this serious risk while on ECMO.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥18 years of age
• • Peripheral Venoarterial-Extracorporeal membrane oxygenation
• • Sedated
• Exclusion Criteria:
• • Any limb ischemia diagnosis prior to ECMO cannulation
• • Any severe extremity trauma that precludes insertion of device
• • Very poor prognosis (survival \>72 hours is unlikely), which also includes severe coagulopathy. Severely coagulopathic patients are at risk for severe hemorrhage and thus may not survive fasciotomy.