The Diagnostic Sensitivity and Specificity of Continuous Pressure Monitoring: Results From Two Prospective Clinical Trials

Thursday, October 19, 2023

8:00 AM – 5:00 PM PST

Location: Skybridge Lobby

Presenting Author(s)

Ross K. Leighton, MD, FIOTA (he/him/his)

Professor
Dalhousie unuiversity
Dalhouise University
Halifax, Nova Scotia, Canada

Disclosure(s): Johnson and Johnson: Grant or Research Support, or I am listed as the PI (Ongoing), Speakers Bureau (Ongoing); MYO-1: Consultant (Ongoing), Speakers Bureau (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); Oseobiologics: Consultant (Ongoing), Speakers Bureau (Ongoing); Smith and Nephew: Grant or Research Support, or I am listed as the PI (Ongoing), Speakers Bureau (Ongoing); Zimmer: Grant or Research Support, or I am listed as the PI (Ongoing), Speakers Bureau (Ongoing)

Corresponding Author(s)

AT

Abdelkrim Temzi

Sr Manager Clinical Affairs & Professional Education
MY01 Inc
Montreal, Quebec, Canada

Disclosure information not submitted.

Co-Author(s)

MB

Mohamed Ali M Balhareth, MD

Faculty of Medicine
Mitchell Bernstein, MD

Associate Professor
McGill University Health Center
Montreal, Quebec, Canada
Prism Schneider, MD, PhD (she/her/hers)

Associate Professor and Orthopaedic Trauma Surgeon
University of Calgary
Calgary, Alberta, Canada
PG

Pierre Guy, MD

Universoity of British Columbia
AL

Allan Liew, MD
DR

Dominique Rouleau, MD
JH

Jeremy Hall, MD

St. Michael's Hospital
AL

AbdelRahman Lawendy, MD
Sp

Stephane pelet, MD
Job N. Doornberg, MD, PhD

UMC Groningen
University Medical Centre Groningen
Groningen, Groningen, Netherlands
RJ

Ruurd L. Jaarsma

Flinders University and Flinders Medical Centre

Purpose: Acute compartment syndrome (ACS) is a rare but serious condition in which increased pressure within a confined space leads to ischemia and necrosis of tissues. Early diagnosis and management are critical for preventing long-term complications.

Methods: Two prospective clinical studies were conducted with 150 patients across 9 sites in Canada. The studies aimed to evaluate the management of ACS using a combination of clinical signs and continuous pressure monitoring (using a Health Canada license device). Patients with suspected 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.

Results: The results of the study showed that the combination of clinical signs and continuous pressure monitoring with the MY01 device improved the accuracy of diagnosis and management of ACS. The results showed that the use of continuous pressure monitoring reduced the time to diagnosis and intervention and improved the outcomes of the patients. The sensitivity and specificity of the test were both >99% with no missed cases of ACS or false positives. Results indicate that pressure trends predated the onset of clinical signs and could serve as an earlier predictor.

Conclusion: The study concluded that the combination of clinical signs and continuous pressure monitoring with the MY01 device 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 patients. The study highlights the need for further research to evaluate the long-term outcomes and the cost-effectiveness of continuous pressure monitoring in the management of ACS.