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NCT05830721 · ClinicalTrials.gov registry record · NA
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
A NA study of Extracorporeal Membrane Oxygenation Complication and Compartment Syndrome of Leg, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT05830721 is a NA study of Extracorporeal Membrane Oxygenation Complication and Compartment Syndrome of Leg that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 6 participants, below the 837-participant average among 8 other Extracorporeal Membrane Oxygenation Complication trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05830721, a NA study of Extracorporeal Membrane Oxygenation Complication and Compartment Syndrome of Leg, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Standard of Care
- DEVICE MY01 + Standard of Care
- DEVICE 14-Gauge Slit Catheter + Standard of Care
Study Locations (1)
Maryland
- The Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-01-02 |
| Est. Completion | 2027-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05830721
The ClinicalTrials.gov registry entry for NCT05830721 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 837-participant average among 8 other Extracorporeal Membrane Oxygenation Complication trials with a reported enrollment target (99% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Extracorporeal Membrane Oxygenation Complication appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT05830721 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05830721 about?
NCT05830721 is a clinical study titled "Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients". 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 ...
What is the current status of trial NCT05830721?
This trial is currently recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2024-01-02. Estimated completion is 2027-12.
What conditions does trial NCT05830721 study?
This clinical trial studies the following conditions: Extracorporeal Membrane Oxygenation Complication, Compartment Syndrome of Leg, Limb Ischemia, Limb Ischemia, Critical.
What interventions are being tested in trial NCT05830721?
The interventions under investigation include: Standard of Care (OTHER), MY01 + Standard of Care (DEVICE), 14-Gauge Slit Catheter + Standard of Care (DEVICE).
Who is sponsoring clinical trial NCT05830721?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05830721 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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