Home › Chronic Limb-Threatening Ischemia › NCT05830721

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

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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 Monitor, allows for continuous pressure readings instead of a single measurement. Multiple measurements may allow for much greater accuracy in diagnosing ACS, which may result in faster time to surgery and potentially save more limbs than single measurements. This device may also be less invasive than an older method of continuous pressure measuring, which uses a needle and tubing that is 14-gauge in size. Therefore, this study aims to compare 3 different types of methods for diagnosing ACS in patients on ECMO, which are 1) Standard of Care, 2) Standard of Care and MY01, and 3)Standard of Care and 14-gauge slit catheter.

What is being tested

• MY01 + Standard of Care (device)
• 14-Gauge Slit Catheter + Standard of Care (device)
• Standard of Care (other)

Sponsor: Johns Hopkins University · Participants: 6 · Started: Jan 2, 2024

Contact the study team

• Henry T Shu, BS · Phone: 2408050284
• Babar Shafiq, MD, MSPT · Phone: 2024218697

Official record on ClinicalTrials.gov — NCT05830721

Locations in the U.S.

Conditions

• Chronic Limb-Threatening Ischemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.