Actively Recruiting
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Led by Johns Hopkins University · Updated on 2025-12-24
6
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Receiving peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO)
- Currently sedated
You will not qualify if you...
- Any limb ischemia diagnosis before ECMO cannulation
- Severe leg trauma preventing insertion of monitoring device
- Very poor prognosis with unlikely survival beyond 72 hours, including severe bleeding risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
H
Henry T Shu, BS
CONTACT
B
Babar Shafiq, MD, MSPT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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