Pressure Monitoring for Compartment Syndrome

(VA-ECMO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Babar Shafiq, MD, MSPT

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Limb ischemia, Severe trauma, Poor prognosis

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Continuous Compartment Pressure Monitoring for Compartment Syndrome?

Continuous compartment pressure monitoring is recognized as one of the few reliable methods to help diagnose acute compartment syndrome, as it can continuously and accurately measure pressure changes in the muscle compartments. The MY01 device, a new digital monitoring system, has been used successfully in patients to monitor these pressures, indicating its potential effectiveness in managing this condition. ^{1 2 3 4 5}

Is continuous compartment pressure monitoring safe for humans?

Continuous compartment pressure monitoring, including devices like the MY01, is generally considered safe and is used to help diagnose conditions like acute compartment syndrome. However, there is a rare case where a similar pressure monitoring device led to compartment syndrome, suggesting that care should be taken in its use, especially during long surgical procedures. ^{1 2 3 4 5}

How is the Continuous Compartment Pressure Monitoring treatment different from other treatments for compartment syndrome?

The Continuous Compartment Pressure Monitoring treatment is unique because it uses a minimally invasive digital device to continuously and precisely measure pressure inside muscle compartments, helping to diagnose and manage acute compartment syndrome more accurately than traditional methods. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for adults over 18 on VA-ECMO who are sedated. It's designed to help those at risk of acute compartment syndrome, a condition where limbs lose blood flow often due to ECMO itself.

Inclusion Criteria

I am 18 years old or older.

I am currently under sedation.

You have a peripheral venoarterial-extracorporeal membrane oxygenation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monitoring for compartment syndrome using different methods: Standard of Care, MY01 device, and 14-gauge slit catheter.

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, including outcomes such as amputation and survival.

Up to 1 year

Treatment Details

Interventions

• Continuous Compartment Pressure Monitoring (Procedure)

Trial Overview The study compares three methods for diagnosing ACS in ECMO patients: standard care alone, standard care with continuous pressure monitoring using the MY01 device, and standard care plus a traditional needle method (14-gauge slit catheter).

Participant Groups

Group I: MY01 + standard of care group Experimental Treatment 2 Interventions

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

Group II: 14-gauge slit catheter monitor + standard of care Experimental Treatment 2 Interventions

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

Group III: Standard of Care Active Control 1 Intervention

This arm involves standard of care monitoring.

Continuous Compartment Pressure Monitoring is already approved in Canada for the following indications:

🇨🇦 Approved in Canada as MY01 Continuous Compartment Pressure Monitor for:

• Diagnosis of Acute Compartment Syndrome in VA-ECMO patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Johns Hopkins Hospital Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

The estimated sensitivity and specificity of compartment pressure monitoring for acute compartment syndrome. [2022] The aim of our study was to document the estimated sensitivity and specificity of continuous intracompartmental pressure monitoring for the diagnosis of acute compartment syndrome.

2. United States pubmed.ncbi.nlm.nih.gov

Novel digital continuous sensor for monitoring of compartment pressure: a case report. [2023] The American Academy of Orthopaedic Surgeons has recently identified continuous intracompartmental pressure monitoring as 1 of the few means to assist in ruling out acute compartment syndrome (ACS). There are very few methods that allow this measurement. This manuscript describes the use of a new digital monitoring system for ACS in 3 patients. This minimally invasive device, the MY01 (NXTSENS, Montreal, Canada) is capable of continuously and precisely measuring variations in intracompartmental pressure.

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Instrumental muscle pressure measurement in acute and chronic compartment syndrome]. [2016] Acute compartment syndrome is a serious complication of trauma to the extremities. Increases in intra-compartmental tissue pressure result from increases in fluid pressure. The indication for a fasciotomy in impending compartment syndrome depends on the tissue pressure. To facilitate the diagnosis of high intramuscular pressure in acute and chronic compartment syndrome, we have developed a pressure monitor that enables us to measure pressure simply and exactly. The pressure monitor has a very low drift, high accuracy and linearity, and is easy to handle. The clinical application of the pressure monitor proved to be a useful tool in the management of an injured limb. This article reviews the pathophysiology and mechanism of acute and chronic compartment syndrome as well as the intracompartmental pressure monitoring.

4. United States pubmed.ncbi.nlm.nih.gov

Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome. [2022] We recommended that all patients at risk for acute compartment syndrome undergo continuous intracompartmental pressure monitoring.

5. England pubmed.ncbi.nlm.nih.gov

Compartment syndrome after use of an automatic arterial pressure monitoring device. [2019] A case of compartment syndrome is reported as a rare complication of the use of a continuous arterial pressure monitoring device. For surgical procedures of very long duration, the way in which these monitoring devices are used may need to be modified, or alternative forms of pressure monitoring used.

6. United States pubmed.ncbi.nlm.nih.gov

The reliability of measurement of tissue pressure in compartment syndrome. [2013] Although there is general agreement as to the pathophysiology and treatment of compartment syndrome and the importance of intramuscular pressure measurements, there are many methods described to obtain these measurements. Variations in experimental measurements using current electronic monitoring, needle, and catheter devices of 18 to 22 mmHg are reported and are enough to cause errors in clinical decision-making that could result in significant clinical consequences. Current unacceptable reliability has been reported with the use of bevel-tipped needles and the clinical Whitesides technique. Because this is contrary to the authors' cumulative clinical and research experience with various methods when properly used (with the small required saline flush to assure a fluid continuum between tissue and the pressure monitor), this study was designed to clarify these problems. Although the two Whitesides techniques (original and clinical) are not in current use where digital methods are available, the clinical method is still used in the Third World.