Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 years of age

• Peripheral Venoarterial-Extracorporeal membrane oxygenation

• Sedated

Locations
United States
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Henry T Shu, BS
hshu5@jhmi.edu
2408050284
Backup
Babar Shafiq, MD, MSPT
bshafiq2@jhmi.edu
2024218697
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 6
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov