NCT05830721 Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
| NCT ID | NCT05830721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Compartment Syndrome of Leg |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2024-01-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Babar Shafiq, MD, MSPT
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05830721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Compartment Syndrome of Leg. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05830721 currently recruiting?
Yes, NCT05830721 is actively recruiting participants. Contact the research team at hshu5@jhmi.edu for enrollment information.
Where is the NCT05830721 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05830721 clinical trial?
NCT05830721 is sponsored by Johns Hopkins University. The principal investigator is Babar Shafiq, MD, MSPT at Johns Hopkins University. The trial plans to enroll 6 participants.