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

This study is looking at ways to detect a serious condition called compartment syndrome in patients who are on a life support machine called VA-ECMO (Venoarterial-Extracorporeal Membrane Oxygenation). Compartment syndrome happens when pressure builds up in a part of the body, often the leg, and can cut off blood flow. Because patients on VA-ECMO are often sedated, it's hard to know if they have compartment syndrome. This study will compare two devices, MY01 and a 14-Gauge Slit Catheter, which are inserted into the leg to continuously measure pressure, against the usual method of checking the leg by physical exam. The study aims to see if these devices can help diagnose compartment syndrome, reduce the need for amputation, and prevent deaths in these patients. You might be able to join if you are an adult (18 or older) on peripheral VA-ECMO and are sedated.

Study design
This interventional study plans to enroll 6 participants. It will compare two different devices for monitoring leg pressure against standard physical exams.
What's involved
If you participate, a device (MY01 or 14-Gauge Slit Catheter) would be inserted into your leg within 6 hours of starting ECMO, or your leg would be checked by physical exam every 4 hours for the first 24 hours.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until the end of their hospitalization, which could be up to one year, to check for compartment syndrome, amputation, or death.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05830721

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

Recruiting
NAAges 18+InterventionalDiagnostic
Johns Hopkins University
~6 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:MY01 + Standard of Care14-Gauge Slit Catheter + Standard of CareStandard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Diagnosed Compartment syndrome
Measured over Up to end of hospitalization, which can be up to 1 year
+3 more outcomes measured
Compartment Syndrome of Leg
Extracorporeal Membrane Oxygenation Complication
Limb Ischemia
Limb Ischemia, Critical
1 sites across 1 states
Maryland1
  • Babar Shafiq, MD, MSPT · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adults ≥18 years of age
Peripheral Venoarterial-Extracorporeal membrane oxygenation
Sedated

Exclusion

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.
  • Number of Participants with Diagnosed Compartment syndromeUp to end of hospitalization, which can be up to 1 year

    Diagnosis of compartment syndrome

  • Number of Participants that Require AmputationUp to end of hospitalization, which can be up to 1 year

    If amputation is performed during hospitalization

  • Number of Deaths During HospitalizationUp to end of hospitalization, which can be up to 1 year

    Mortality

  • Number of Participants with Amputation-free survivalUp to end of hospitalization, which can be up to 1 year

    Survival of hospitalization without amputation