ACS Monitoring Charité Berlin

Compartment Syndromes Clinical Trial

Official title:

Non-invasive Monitoring of Patients at Risk of Acute Compartment Syndrome (ACS) With CPMX1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030635
• Other study ID #: 1056
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: March 25, 2024

Study information

• Verified date: January 2024
• Source: Compremium AG
• Contact: Vincent Baumann
• Phone: +41 79 933 96 48
• Email: v.baumann[@]compremium.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compartment Syndromes
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Germany	Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Compremium AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of adverse events	Safety of the device will be assessed by systematically reporting adverse events and serious adverse events (description, severity, relation to the procedure) and by monitoring the frequency and incidence of these 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)
Other	Assessment of device deficiencies	Safety of the device will be assessed by systematically reporting device deficiencies (description of the deficiency) and by monitoring the frequency and incidence of these 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)
Other	New risk identification	The practitioner will be asked to identify any new risks arising when using the investigational device.	At the end of the participation of each investigator to the clinical study (up to 5 months)
Primary	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	CP Value [percent] trend over time	Each study patient will be monitored every hour for a total of 8 hours (measurement time might be extended in case of trauma-related surgery during the measurement period and/or in case measurements are spaced further apart) with the investigational device. The CP Value [percent] trend over time will be visualized per patient through plots.	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	CP Values [percent] from the compartments at risk of ACS and CP Values [percent] of compartment not at risk at the same time.	CP Value [percent] of extremities at risk and not at risk of ACS will be 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	Quotient CP Value [percent]	Quotient calculation will be performed between CP Value of affected and non-affected limb's compartment. Values will be contrasted between the groups.	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	Time of the lowest CP Values [percent] (highest compartmental pressure) for the compartment at risk of ACS	The mean time point for lowest CP Values [percent] and range will be calculated.	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	Usability and workflow assessment	Usability and workflow assessment will be evaluated through a practitioner's questionnaire which will be filled by each investigator at the end of the participation in the clinical investigation. The questionnaire will cover different aspects regarding usability and safety of the CPMX1 device.	At the end of the participation of each investigator to the clinical study (up to 5 months)