THE DIAGNOSTIC ACCURACY OF MICROELECTRIC MECHANICAL SYSTEM-BASED CONTINUOUS PRESSURE MONITORING: RESULTS FROM TWO PROSPECTIVE CLINICAL TRIALS

Acute Compartment Syndrome (ACS) is a painful condition caused by increased intracompartmental pressure (ICP) within a determined myofascial compartment [1]. ACS is a surgical emergency that, if left untreated, may result in serious irreversible complications, limb loss, or even death [2]. It is difficult to diagnose in clinical practice and remains primarily a clinical diagnosis [3]. Intracompartmental pressure monitoring (ICP) has been postulated to be a better diagnostic proxy for physicians [4]. The main limitation of single-point measurements is that ACS is an evolving condition that requires serial reassessment both for clinical signs as well as ICP. Continuous pressure monitoring has been studied as an aid in the diagnosis of ACS and has shown high levels of both specificity and sensitivity [5]. MY01 is a continuous compartmental pressure monitor. The device allows for real-time continuous monitoring of intracompartmental pressure for up to 18 hours, while its mobile app provides clinicians with remote data display capabilities. The aim of this trial is to evaluate the safety and functionality of MY01 (the device) in patients at risk of developing ACS Two prospective clinical studies were conducted with 150 patients across nine sites in Canada. The studies aimed to evaluate the management of ACS using a combination of clinical signs and a Micro Electric Mechanical System (MEMS)-based continuous pressure monitoring a Health Canada and FDA licensed device). Patients with a high risk of developing ACS were included in the study, and their clinical and demographic data were collected. Continuous pressure monitoring was performed, and the results were compared with the clinical signs of ACS. One hundred and fifty participants were enrolled from November 2020 through March 2023 across nine sites in Canada. Medical notes and radiographs were reviewed, data was collected, and patients’ demographics and injury information are consistent with the most at-risk ACS population. The demographics of enrolled patients, mechanisms of injury, and fracture types are in line with the most at-risk population. We have excluded 17 patients (11%) as some of them showed an abnormal reading due to insertion technical issues, early in the study, and others have the device removed before collecting enough data for the need of MRI or removed by the patients themselves. There were no missed compartment syndromes and no false positives identified during device use. Pain levels were found to highly vary in patients that did not have ACS, complicating the ability to both rule out or rule in the syndrome. Compared to pain alone, the leading subjective clinical sign when diagnosing ACS, continuous pressure monitoring was found to provide a more objective picture of the disease evolution. A significant number of patients reported high pain level (>7/10 VAS) but exhibited low ICP values. Pre-operative intracompartmental pressures were lower than post-operative pressures (18.9mmHg vs 27.2mmHg), a phenomenon that is likely due to surgical manipulation and initial post-surgical swelling. However, consistent with observations from previous research, post-operative pressures typically began to trend downward within two hours post-surgery. Only one patient that developed ACS post-operatively had a full pressure profile recorded, the other patient had the device removed after 2 hours to be taken to the MRI scan. The curve decreased initially, halted after 4 hours, and plateaued before increasing, along with a concomitant decrease in perfusion pressure that did not improve within 2 hours The study concluded that the combination of clinical signs and continuous pressure monitoring is a valuable tool for the management of ACS. The results showed that the use of the continuous pressure monitoring improved the accuracy of diagnosis, reduced the time to intervention, and improved the outcomes of the patients. This study provides evidence for the clinical utility of continuous pressure monitoring in the management of ACS and highlights the importance of early detection and prompt intervention in the management of this condition. The study also showed the utility of the device in determining the possibility of ACS in neurologically impaired or moribund patient(intubated). The study highlights the need for further prospective trials to evaluate the long-term outcomes and the cost effectiveness of continuous pressure monitoring in the management of ACS.