ACS Monitoring Charité Berlin

Summary

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.

In the diagnosis of acute compartment syndrome, clinical suspicion supplemented by careful, repeated clinical examination continues to be the clinician's greatest tool. The classic signs and symptoms of acute compartment pressure are often listed as the 5 or 6 "Ps": Pain, Pressure, Pulselessness, Paralysis, Paresthesia, and Pallor. The diagnosis is typically not made by using equipment and it is difficult in the awake and oriented patient, becoming even more problematic in the polytrauma patient.

An alternative diagnostic method for compartment syndrome is invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. However, literature shows that commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and that user errors are common.

Compared to the invasive modalities or just experience of the surgeon, the CPMX1 shows promising advantages for the clinical application. Not only is the technology used for the CPMX1 device safe and non-invasive for the patient with only initial training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and confirmed in clinical setting). Recently, two clinical studies ("SWISS\_EVIDENCE" and "SWISS\_CLEARANCE") were conducted using the CPMX1 in healthy volunteers in a real-world clinical environment. Results of these studies confirmed that the application of the CMPX1 in patient care is safe and validated the reliability of compressibility ratio measurement with the CPMX1 in healthy volunteers.

The use of the CPMX1 device therefore facilitates the measurements, as it is based on pre- existing ultrasound methods, and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.

Conditions

• Compartment Syndromes

Interventions

DEVICE

Measurement of compartment compressibility using the CPMX1 device

Patients will be monitored about every hour (+/- 30 min) for a total of 8 hours. Measurement time might be extended in case the patient undergoes trauma-related surgery during the measurement period and/or in case measurements are spaced further apart. Remaining measurements will be completed after the surgery. At each time point, three measurements of compartment compressibility will be conducted using the CMPX1 on both the affected (potential ACS) and healthy limb.

Sponsors & Collaborators

• Compremium AG

  lead INDUSTRY

Principal Investigators

• Tobias Gehlen, Dr med · Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-25

Primary Completion

2024-10-22

Completion

2024-10-22

Countries

• Germany

Study Locations