MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Acute Compartment Syndrome Clinical Trial

Official title:

MY01 - An Aid for Diagnosing Acute Compartment Syndrome in Real Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016103
• Other study ID #: MY01 - QC - 01
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: MY01 Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes
• Syndrome

Intervention

Device:
• MY01 - Continuous Compartmental Pressure Monitor
Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montreal	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
MY01 Inc.	Hopital du Sacre-Coeur de Montreal, McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical ease with which the new compartment pressure monitor was inserted into compartment.	At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you the device functioned adequately?" [0 = not confident] - [10 = very confident].; The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 10 should be considered a very positive scenario, whereas a record of 0 should indicate a very negative scenario.	24-48 hours following device insertion
Primary	Ability to monitor in real-time the continuous pressure read-out from the compartment in remote locations such as an I-phone.	At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate in a Yes or No question "Did the MY01 Application remote data display work properly?" [Yes] or [No].	24-48 hours following device insertion
Primary	The correlation of continuous pressure read-outs (high, normal or low) with clinical indications for compartment syndrome in each patient.	Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's [Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia]), and compared against the pressure readout [mmHG] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.	24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Secondary	Correlation of clinical compartment syndrome release with data from the continuous pressure monitor read-out.	Should surgical fasciotomy be deemed necessary to release pent up pressure in the patients muscle compartment, the continuous pressure read-outs [mmHG] derived from the device will be compared against the timeframe when the decision to conduct fasciotomy was made.	24-48 hours following device insertion, and again during the final follow-up of the participant approximately two weeks after treatment
Secondary	Short-term outcomes of the patient following continuous pressure monitoring	Survey and tabulation of data from patient clinical findings.	24-48 hours following device insertion.