Clinical trial NCT05367921: SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1
Official title: Clinical Validation of CPM#1 Compression Ratio Measurement on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compartment Syndromes
Lead sponsor: Compremium AG
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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 minimal 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.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Male and female
* Age between 18 and 84

Exclusion Criteria:

* Previous surgery to or fracture of the lower leg
* Peripheral arterial or venous disease
* History of compartment syndrome
* Limb anomalies
* General muscle disorder
* Participants under the influence of excessive alcohol, consumption of narcotics or benzodiazepines prior to procedure
* Participants under the effect of analgesic (\< 12 hours)

Primary outcomes:
measure: Inter-operator reproducibility with 3 raters
timeFrame: During the procedure which should last about 10 min/patient
Secondary outcomes:
measure: Intra-operator reproducibility
timeFrame: During the procedure which should last about 10 min/patient
measure: Participant's reported pain: baseline
timeFrame: Before (5 min before procedure).
measure: Participant's reported pain: at highest externally applied pressure
timeFrame: During the procedure (the procedure will last about 10 min/patient)
measure: Participant's reported pain: after the procedure
timeFrame: Immediately after procedure (no follow up is planned)
Other outcomes:
measure: Assessment of adverse events
timeFrame: During the procedure which should last about 10 min/patient
measure: Assessment of device deficiencies
timeFrame: During the procedure which should last about 10 min/patient
measure: New risk identification
timeFrame: Within 12 hours after procedure (no follow up is planned)
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital
Study officials:
affiliation: Department für Orthopädie und Traumatologie, Inselspital Bern
name: Helen Anwander, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: