What is the MY01 device studying for patients on VA-ECMO?

The MY01 device is being studied to see if it can more accurately detect acute compartment syndrome (ACS) in patients on venoarterial extracorporeal membrane oxygenation (VA-ECMO). Researchers want to compare this continuous pressure monitoring device with standard care and another continuous device to improve early diagnosis and treatment. The study is sponsored by Johns Hopkins University.

Who may be eligible for this compartment syndrome clinical trial?

Adults 18 years or older who are sedated and on peripheral VA-ECMO may be eligible. Participants should not have any limb ischemia diagnosis before ECMO or severe leg injuries that prevent device insertion. Please review eligibility criteria for more details.

Is there any cost to participate in this compartment syndrome clinical trial?

Study-related care, including the devices and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05830721

Monitoring Compartment Pressure to Detect Compartment Syndrome in Adults on Venoarterial ECMO A Preliminary Feasibility Study Comparing Standard Care and New Devices

Led by Johns Hopkins University · Updated on 2025-12-24

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Acute compartment syndrome ACS is a serious surgical emergency that can occur in patients receiving extracorporeal membrane oxygenation ECMO, especially veno-arterial VA ECMO. ACS happens when increased pressure in a muscle compartment reduces blood flow, leading to limb damage. Diagnosing ACS in ECMO patients is difficult because they are usually sedated and cannot report symptoms like pain. This study evaluates and compares three methods to diagnose ACS the current standard of care, the new MY01 Continuous Compartment Pressure Monitor device alongside standard care, and a 14-gauge slit catheter device with standard care, aiming to improve accuracy and early detection. Participants will be randomly assigned to one of three groups. The standard care group involves physical exams every 4 hours and single pressure needle measurements if ACS is suspected. The MY01 group will have the device inserted into the leg near the ECMO tubing to continuously monitor pressures for 24 hours, with data accessible via a mobile app. The 14-gauge slit catheter group will use tubing inserted into the leg, connected to a monitor with pressure readings recorded every 4 hours for 24 hours. If ACS is diagnosed, surgery decisions will be made by the medical team. The device is removed after monitoring or upon diagnosis. During the study, participants will undergo regular physical exams and pressure monitoring according to their assigned group. Researchers will track the number of patients diagnosed with ACS, those needing amputation, deaths during hospitalization, and amputation-free survival, with follow-up lasting up to one year. Monitoring will include continuous or intermittent pressure measurements and clinical assessments. The study will help assess the effectiveness of continuous pressure monitoring devices compared to standard care in detecting ACS and potentially improving treatment timing and limb outcomes.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	MY01 device with standard care	14-gauge slit catheter with standard care	Standard of care
What is it?	A continuous compartment pressure monitoring system using the MY01 device, inserted into the leg on the ECMO side and monitored via a digital app for 24 hours alongside standard care.	Continuous compartment pressure monitoring using a 14-gauge slit catheter inserted into the leg and connected to a pressure monitor for 24 hours, as well as standard care.	Serial nurse-performed physical exams of the at-risk leg every 4 hours for the first 24 hours after ECMO, with compartment pressures checked by needle device only if ACS is suspected.
Role in the study	Investigational arm assessing whether continuous monitoring with MY01 improves early diagnosis of ACS in at-risk VA-ECMO patients.	Investigational comparator evaluating a conventional continuous pressure monitoring approach, compared to MY01 and standard care.	Serves as the control arm reflecting usual practice for diagnosing ACS in VA-ECMO patients.
Primary use	Provides real-time continuous monitoring of compartment pressure to facilitate earlier detection and intervention for ACS risk.	Enables continuous recording of intracompartmental pressure to support earlier ACS diagnosis and intervention.	Aims to detect ACS through scheduled physical exam by trained staff, with pressure measured only if symptoms or signs are suggestive of ACS.
How is it performed?	MY01 sensor inserted into leg muscle compartment by an orthopedic surgeon within 6 hours of ECMO, connected to real-time mobile monitoring for 24 hours.	14-gauge slit catheter inserted into leg compartment by clinician, pressure data recorded by nurse or technician every 4 hours for 24 hours.	Leg examined by nurse every 4 hours for signs of ACS for first 24 hours after ECMO; pressure measured with needle device only if ACS is suspected.
Evidence status	Continuous digital pressure monitoring is under investigation for clinical effectiveness and safety in the VA-ECMO population; published device studies in trauma populations suggest feasibility but evidence in ECMO is limited.	Continuous slit catheter monitoring has demonstrated technical feasibility and some diagnostic value in trauma and perioperative populations, but limited published evidence specifically in ECMO patients.	Serial clinical exams with selective pressure measurement for ACS remain recommended as current standard practice, though early diagnosis may be challenging in sedated or critically ill patients.
Important limitations	Limited evidence exists for MY01 use specifically in ECMO patients. Device may have technical or insertion challenges, and impact on clinical outcomes remains unproven.	Potential for device-related complications such as bleeding or infection; limited comfort data in sedated ECMO patients; clinical outcome benefit for continuous monitoring is not established.	Diagnosis based on clinical assessment may be delayed in sedated or critically ill patients; sensitivity of physical exam alone is limited, especially in ECMO context.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years of age or older
Receiving peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO)
Sedated during ECMO treatment

You will not qualify if you...

Any limb ischemia diagnosis before ECMO cannulation
Severe extremity trauma preventing device insertion
Very poor prognosis with expected survival less than 72 hours, including severe coagulopathy

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants must be adults receiving peripheral VA-ECMO and sedated during treatment, without prior limb ischemia or severe trauma preventing device insertion.

Device Implementation

Duration - Up to 24 hours

Participants have a device inserted into the leg on the same side as the ECMO tubing to continuously monitor compartment pressures. This occurs within 6 hours of ECMO start. Monitoring lasts for 24 hours, after which the device is removed or earlier if compartment syndrome is diagnosed.

1 insertion visit and continuous monitoring for 24 hours

Standard of Care Monitoring

Duration - 24 hours

Participants receive physical exams every 4 hours for the first 24 hours to monitor for signs of compartment syndrome. If suspicion arises, an orthopedic surgeon evaluates and may perform a single pressure measurement. Monitoring stops if diagnosis is made.

Physical exams every 4 hours during 24-hour monitoring

Follow-up

Duration - Up to 1 year

Participants are followed up for up to 1 year during their hospitalization to track outcomes such as diagnosis of compartment syndrome, amputations, and survival.

Follow-up visits and assessments as part of hospitalization care