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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to diagnose acute compartment syndrome (ACS), a condition where a limb loses blood flow, in patients on ECMO (a machine that aids breathing and heart function). ACS is difficult to detect in these patients because sedation prevents them from reporting symptoms. The trial compares three methods: usual care, usual care plus a new device called MY01 for continuous compartment pressure monitoring, and usual care plus an older continuous monitoring method. Sedated patients on ECMO, especially those without prior limb blood flow issues before ECMO, might be suitable for this trial. The goal is to identify the best way to quickly and accurately diagnose ACS, potentially saving more limbs.

As an unphased trial, this study explores innovative diagnostic methods, offering participants a chance to contribute to potentially life-saving advancements.

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 prior data suggests that these methods for diagnosing ACS are safe?

Research shows that the MY01 Continuous Compartment Pressure Monitor gently measures pressure inside muscles in real time. It helps doctors quickly and accurately diagnose acute compartment syndrome, a condition where muscle pressure becomes dangerously high, allowing for faster treatment. The device is likely safe and well-tolerated.

Studies indicate that the 14-gauge slit catheter monitor effectively tracks pressure with high accuracy. However, it requires inserting a fluid-filled tube into the muscle, making it more invasive than the MY01 device. Both methods are generally used in medical settings to catch problems early and prevent serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced techniques for monitoring compartment syndrome, a serious condition that can cause muscle and nerve damage. Unlike the standard practice, which involves periodic checks, these experimental approaches offer continuous monitoring through innovative devices. The MY01 device and the 14-gauge slit catheter provide real-time pressure data, potentially catching dangerous changes earlier. By integrating these methods with standard care, the trial aims to improve patient outcomes through more timely and accurate diagnosis.

What evidence suggests that this trial's methods for diagnosing acute compartment syndrome could be effective?

Research has shown that the MY01 Continuous Compartment Pressure Monitor, which participants in this trial may receive, accurately tracks pressure changes in muscle areas. This device enables ongoing pressure checks, potentially improving the diagnosis of acute compartment syndrome (ACS). Early findings suggest that continuous monitoring could lead to quicker surgeries and better chances of saving limbs compared to single pressure checks.

The trial will also study the 14-gauge slit catheter, which has proven effective in tracking pressure over time, with a high ability to correctly identify those with the condition (94% sensitivity) and those without it (98% specificity). Both the MY01 device and the 14-gauge slit catheter are being evaluated in this trial for their potential to improve ACS diagnosis, providing more consistent and accurate readings than traditional methods. ^{1 2 3 4 6}

Who Is on the Research Team?

Babar Shafiq, MD, MSPT

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6407949/

Continuous Intracompartmental Pressure Monitoring for Acute ...

We recommended that all patients at risk for acute compartment syndrome undergo continuous intracompartmental pressure monitoring.

2.

fda.gov

fda.gov/media/141904/download

Classification of Intracompartmental Pressure Monitor ...

The cleared devices use one of two methods to measure pressure. 1) Slit catheter: fluid-filled catheter inserted in the compartment and measures.

3.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK553900/

Pressure Measurement: Surrogate of Ischaemia - NCBI

Intracompartmental pressure monitoring of at risk patients has recently been found to have a high sensitivity (94%) and specificity (98%) when utilising a slit ...

4.

arxiv.org

arxiv.org/pdf/2401.10386

Noninvasive Acute Compartment Syndrome Diagnosis ...

The wick catheter and slit catheter focus on in- creasing the surface area of pressure assessments to increase accuracy measures, however precision may ...

5.

fda.gov

fda.gov/media/141852/download

Intracompartmental Pressure Monitor Executive Summary

The device is intended for monitoring of intracompartmental pressures to aid in the diagnosis of compartment syndrome, defined as a condition in ...

6.

aofas.org

aofas.org/docs/default-source/research-and-policy/appropriate-use-criteria-clinical-practice-guidelines/acute-compartment-syndrome-clinical-practice-guidelines.pdf?sfvrsn=93338d04_2

acute-compartment-syndrome-clinical-practice-guidelines. ...

compartment syndrome? 5. For patients with missed/late extremity compartment syndrome, can pressure monitoring determine relative need/timing of fasciotomy ...