SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1

Validation of CPM#1 Compressibility Ratio in a Clinical Study of Healthy Volunteers: Evaluation of the Test-retest Repeatability

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially 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.

Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra- compartmental pressure within 6 to 10 hours.

The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.

Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 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 clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 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.

Study Overview

• Status: Completed
• Conditions: Compartment Syndromes
• Intervention / Treatment: Device: Measurement of compartment compressibility

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Universitäres Notfallzentrum, Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteer
• Male or female
• Age 18 to 84 years

Exclusion Criteria:

• Previous surgery to or fracture of the leg and/or forearm
• Peripheral arterial or venous disease
• History of compartment syndrome
• Limb anomalies
• General muscle disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPM#1; Compartment compressibility ratio measurement using the CPM#1 device	Device: Measurement of compartment compressibility; Application of the CPM#1 device for compartment compressibility ratio measurement - for each participant, a pre-defined number of measurements will be conducted per leg and forearm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-operator reproducibility with 3 raters	Inter-operator reproducibility will be assessed using intra-class correlation coefficients (two-way random effects, single rater, absolute agreement). Three independent raters will conduct 4 measurements per compartment site on 14 relaxed forearms (7 volunteers, 1 site per forearm), and 14 relaxed legs (7 volunteers, 2 sites per leg).	During the procedure which should last about 3 hours/patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operator reproducibility	Intra-operator reproducibility will be assessed using intra-class correlation coefficients (two-way mixed effects, single measurement, absolute agreement). Three independent raters will conduct 4 measurements per compartment site on 14 relaxed forearms (7 volunteers, 1 site per forearm), and 14 relaxed legs (7 volunteers, 2 sites per leg).	During the procedure which should last about 3 hours/patient
Validation of number of measurement repetitions	Clinically needed number of measurements for optimized repeatability will be assessed on 2, 3 and 4 measurement repetitions per compartment site based on 14 relaxed forearms (7 volunteers, 1 site per forearm), and 14 relaxed legs (7 volunteers, 2 sites per leg).	During the procedure which should last about 3 hours/patient

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse events and serious adverse events	Safety of the procedure will be assessed by documenting adverse events and serious adverse events (description of the adverse events, number of participants).	During the procedure which should last about 3 hours/patient
Assessment of device deficiencies	Safety of the procedure will be assessed by documenting device deficiencies (description)	During the procedure which should last about 3 hours/patient

Collaborators and Investigators

• Sponsor: Compremium AG
• Investigators: Principal Investigator: Beat Lehmann, Universitäres Notfallzentrum, Inselspital Bern

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes
• Other Study ID Numbers: SWISS_CLEARANCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No