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

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT05830721 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Patients on ECMO can develop this condition for many reasons, but most commonly from the ECMO procedure itself. This most commonly involves the leg. Key symptoms of ACS include severe pain, loss of pulses, loss of feeling, and inability to move the limb. However, because patients on ECMO are often sedated, ACS is difficult to diagnose as patients can not report symptoms. As a result, the only available tool for diagnosing ACS may be measurement of pressures in the limb. This is normally done with a needle-device, which is inserted into the leg for a single measurement. However, a recently developed device, called the MY01 Continuous Compartment Pressure Moni

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📋 Eligibility rules (as published)
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.
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What it tests

  • MY01 + Standard of Care
  • 14-Gauge Slit Catheter + Standard of Care
  • Standard of Care
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Where

1 site
The Johns Hopkins Hospital
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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