Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05830721

Conditions

Compartment Syndrome of Leg

Extracorporeal Membrane Oxygenation Complication

Limb Ischemia

Limb Ischemia, Critical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MY01 + Standard of Care

14-Gauge Slit Catheter + Standard of Care

Standard of Care

Study Details

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.

Conditions

Compartment Syndrome of Leg

Extracorporeal Membrane Oxygenation Complication

Limb Ischemia

Limb Ischemia, Critical

Study ID

NCT05830721

Start date

Jan 2, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

This arm involves standard of care monitoring.

experimental: MY01 + standard of care group

This arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.

experimental: 14-gauge slit catheter monitor + standard of care

This arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.

Interventions

MY01 + Standard of Care

In addition to standard of care, the MY01 device will be inserted by an orthopedic surgeon into the leg on the same side as the ECMO tubing. This will occur within 6 hours of the start of ECMO. Insertion of the device involves a needle, which is removed once the device is inserted. Monitoring of the device will occur as described by the device manufacturer, which includes a mobile application. If at any time the compartment pressures suggest that there may be ACS, an orthopedic surgeon will be called to perform a physical exam. If the physical exam supports the diagnosis of ACS, then an additional pressure measurement with a needle may be also taken to confirm the measurement. If the diagnosis of ACS is made, the decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team. Monitoring of with the device will be done for 24 hours. The device will be removed after 24 hours or if the diagnosis of ACS is made.

14-Gauge Slit Catheter + Standard of Care

For the 14-gauge slit catheter group, the exact same protocol will be followed as the MY01 group. The 14-gauge slit catheter consists of tubing that is 14-gauge in size, which is inserted into the leg with a needle. The needle will be removed once the tubing is inserted. The tubing is then connected to a monitor, which will display the pressure in the leg. Just like the MY01 group, the leg will be numbed and cleaned before the tube is inserted in the leg. Instead of the data being recorded on a mobile device, a nurse or nurse technician will document pressure readings every 4 hours for a total of 24 hours. Once monitoring is finished, the 14-gauge slit catheter will be removed from the leg.

Standard of Care

If assigned to standard of care, the participant will undergo monitoring within 1 hour of the start of ECMO. For standard of care group, this will involve monitoring the leg with the ECMO tubing with physical exam every 4 hours for the first 24 hours. This will be performed by a trained nurse. If at any time there is suspicion for ACS, the physical exam will be verified by an orthopedic surgeon. The orthopedic surgeon will decide if pressure measurements will be necessary. If so, then a single pressure measurement from each compartment will be taken with a needle device. If the ACS diagnosis is made, any further monitoring of that leg is stopped. The decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team, which includes surgeons and medical doctors. This is currently the standard of care at the Johns Hopkins Hospital.

Primary outcome measure

  • Number of Participants with Diagnosed Compartment syndrome [ Time Frame: Up to end of hospitalization, which can be up to 1 year ]
  • Number of Participants that Require Amputation [ Time Frame: Up to end of hospitalization, which can be up to 1 year ]
  • Number of Deaths During Hospitalization [ Time Frame: Up to end of hospitalization, which can be up to 1 year ]
  • Number of Participants with Amputation-free survival [ Time Frame: Up to end of hospitalization, which can be up to 1 year ]

Central Contacts and Locations

Central contacts

Henry T Shu, BS

2408050284hshu5@jhmi.edu

Babar Shafiq, MD, MSPT

2024218697bshafiq2@jhmi.edu

Locations

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Babar Shafiq, MD, MSPT

443-287-7847bshafiq2@jhmi.edu

Henry T Shu

2408050284hshu5@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Compartment Syndrome
  • Venoarterial Extracorporeal Membrane Oxygenation
  • Compartment Pressure Measurement
  • ECMO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-24.