Clinical trial NCT06030635: ACS Monitoring Charité Berlin
Official title: Non-invasive Monitoring of Patients At Risk of Acute Compartment Syndrome (ACS) with CPMX1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compartment Syndromes
Lead sponsor: Compremium AG
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients able to give consent
* Informed consent documented by signature
* Potential acute compartment syndrome (ACS) of the extremities (excl. hands, feet)
* Male or female
* Age 18 to 95 years
* Intact skin at the measurement site
* Open fracture up to Grade I if not in the measurement area

Exclusion Criteria:

* Potential Acute Compartment Syndrome (ACS) of both extremities considered
* Limb anomalies that could hinder the measurement
* Individuals who are deprived of liberty pursuant to an administrative order or court order or approval.

Primary outcomes:
measure: Lowest CP Values [percent] (highest compartmental pressure)
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
Secondary outcomes:
measure: CP Value [percent] trend over time
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: CP Values [percent] from the compartments at risk of ACS and CP Values [percent] of compartment not at risk at the same time.
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: Quotient CP Value [percent]
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: Time of the lowest CP Values [percent] (highest compartmental pressure) for the compartment at risk of ACS
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: Usability and workflow assessment
timeFrame: At the end of the participation of each investigator to the clinical study (up to 5 months)
Other outcomes:
measure: Assessment of adverse events
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: Assessment of device deficiencies
timeFrame: During the procedure which will last 8 hours/patient (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart)
measure: New risk identification
timeFrame: At the end of the participation of each investigator to the clinical study (up to 5 months)
Locations:
city: Berlin
country: Germany
facility: Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin
Study officials:
affiliation: Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin
name: Tobias Gehlen, Dr med
role: PRINCIPAL_INVESTIGATOR
References: