ACS Monitoring Charité Berlin

NCT06030635 | Completed

• 1 other identifier: 1056
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Compartment Syndromes

Outcome Measures

Primary Outcomes (1)

• Lowest CP Values [percent] (highest compartmental pressure)

  Lowest CP Values \[percent\] (highest compartmental pressure) will be assessed from the difference in CP Values \[percent\] using the CPMX1 for a compartment at risk of ACS and compartment not at risk of ACS at the same time, contrasted by a pairwise t-test.

  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 (5)

• CP Value [percent] trend over time

  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)

• CP Values [percent] from the compartments at risk of ACS and CP Values [percent] of compartment not at risk at the same time.

  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)

• Quotient CP Value [percent]

  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)

• Time of the lowest CP Values [percent] (highest compartmental pressure) for the compartment at risk of ACS

  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)

• Usability and workflow assessment

  At the end of the participation of each investigator to the clinical study (up to 5 months)

Other Outcomes (3)

• Assessment of adverse events

  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)

• Assessment of device deficiencies

  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)

• New risk identification

  At the end of the participation of each investigator to the clinical study (up to 5 months)

Study Arms (1)

CPMX1

EXPERIMENTAL

Compartment compressibility measurement using the CPMX1 device

Device: Measurement of compartment compressibility using the CPMX1 device

Interventions

Measurement of compartment compressibility using the CPMX1 device 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.

CPMX1

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Compremium AG: lead

Study Sites (1)

Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin

Berlin, Germany, 13353, Germany

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tobias Gehlen, Dr med

  Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 11, 2023
• Study Start: October 25, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)