Clinical trial NCT04016103: MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time
Official title: MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Compartment Syndrome
Keywords: Acute Compartment Syndrome
Lead sponsor: MY01 Inc.
Sponsor class: INDUSTRY
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Hopital du Sacre-Coeur de Montreal
First posted: 2019-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Compartment syndrome can result from extremity trauma. It can also be caused by procedural cases that involve lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions that can avoid complications. Subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve our accuracy in diagnosing compartment syndrome. Ideally, this would be suited for single and/or continuous pressure read-outs. The aim is to reduce the incidence of missed compartment syndrome and diminish delays that would lead to significant disability.

Despite awareness, delayed diagnosis and treatment occurs in modern orthopaedic practice. As noted in many studies, once a diagnosis has been made, immediate fasciotomy is necessary to provide the best chance for a favourable clinical result. Therefore, there is a need for improved devices in order to obtain an early and reliable diagnosis.


Eligibility criteria: Inclusion Criteria:

* Men or women, aged 18 years of age and older
* Any tibial, foot, femoral, forearm or fracture that is felt by the surgeon to have a reasonable indication that elevated ICP could occur in the patient
* Mentally fit to provide informed consent

Exclusion Criteria:

* Patients with fractures that are not felt to be at risk of developing compartment syndrome based on serial clinical evaluation
* Infected wounds; infected fractures
* Patients who present with ACS requiring urgent surgical fasciotomy
* Patients who cannot consent to trial
* Pregnant women

Primary outcomes:
measure: Clinical ease with which the new compartment pressure monitor was inserted into compartment.
timeFrame: 24-48 hours following device insertion
measure: Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.
timeFrame: 24-48 hours following device insertion
measure: The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.
timeFrame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Secondary outcomes:
measure: Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.
timeFrame: 24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
measure: Short-term outcomes of the patient following continuous pressure monitoring
timeFrame: 24-48 hours following device insertion.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montreal
state: Quebec
Study officials:
affiliation: Staff Surgeon, Orthopaedic Trauma & Limb Deformity, Montreal General Hospital | Assistant Professor Department of Surgery and Pediatric Surgery McGill University
name: Mitchell Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References: