Pressure Monitoring for Compartment Syndrome

(VA-ECMO Trial)

Overseen By Babar Shafiq, MD, MSPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Limb ischemia, Severe trauma, Poor prognosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

6 Participants Needed

Trial Summary

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}

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.

Research Team

Babar Shafiq, MD, MSPT

Principal Investigator

Johns Hopkins University

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 currently under sedation.

You have a peripheral venoarterial-extracorporeal membrane oxygenation.

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

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Continuous intracompartmental pressure monitoring has a high estimated sensitivity of 94% and specificity of 98% for diagnosing acute compartment syndrome in patients with tibial diaphyseal fractures, based on a study of 850 patients.

The method demonstrated a strong negative predictive value of 99%, indicating it is very effective at ruling out acute compartment syndrome, making it a valuable tool for monitoring patients at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The estimated sensitivity and specificity of compartment pressure monitoring for acute compartment syndrome. McQueen, MM., Duckworth, AD., Aitken, SA., et al.[2022]

The MY01 digital monitoring system effectively detects early-stage acute compartment syndrome (ACS) in patients, allowing for timely surgical intervention in two cases.

This device also helps rule out ACS in patients with other medical conditions, preventing unnecessary surgeries and associated complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel digital continuous sensor for monitoring of compartment pressure: a case report. Montreuil, J., Corban, J., Reindl, R., et al.[2023]

A newly developed pressure monitor allows for accurate and easy measurement of intra-compartmental pressure, which is crucial for diagnosing acute compartment syndrome in injured limbs.

The monitor's high accuracy and low drift make it a valuable tool in clinical settings, aiding in the timely management of compartment syndrome to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Instrumental muscle pressure measurement in acute and chronic compartment syndrome]. Witschger, PM., Wegmüller, M.[2016]

Continuous intracompartmental pressure monitoring is recommended for all patients at risk of acute compartment syndrome, with a detailed procedure involving catheter placement and monitoring for at least 24 hours.

In a study of 850 patients with tibial diaphysis fractures, this monitoring technique helps ensure timely detection and management of compartment syndrome, improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome. Duckworth, AD., McQueen, MM.[2022]

A rare case of compartment syndrome occurred due to the use of a continuous arterial pressure monitoring device during a lengthy surgical procedure, highlighting a potential safety risk associated with this monitoring method.

The findings suggest that for long surgeries, modifications in the use of these devices or the consideration of alternative pressure monitoring methods may be necessary to prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compartment syndrome after use of an automatic arterial pressure monitoring device. Vidal, P., Sykes, PJ., O'Shaughnessy, M., et al.[2019]

In a laboratory model for testing compartment syndrome, the slit catheter, side-ported bevel-tipped needle, and 18-gauge bevel-tipped needle provided equivalent and reliable pressure measurements when used with electronic transducer monitoring.

The original Whitesides method using 1.25-mm capillary tubing is a reliable alternative for measuring intramuscular pressure when digital methods are unavailable, while the clinical Whitesides method with 3-mm tubing is less reliable and should be used cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reliability of measurement of tissue pressure in compartment syndrome. Hammerberg, EM., Whitesides, TE., Seiler, JG.[2013]

References

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

The estimated sensitivity and specificity of compartment pressure monitoring for acute compartment syndrome. [2022]

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

Novel digital continuous sensor for monitoring of compartment pressure: a case report. [2023]

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

[Instrumental muscle pressure measurement in acute and chronic compartment syndrome]. [2016]

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

Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome. [2022]

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

Compartment syndrome after use of an automatic arterial pressure monitoring device. [2019]

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

The reliability of measurement of tissue pressure in compartment syndrome. [2013]