SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1

NCT05367921 | Completed

• 1 other identifier: SWISS_EVIDENCE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Compartment Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 one measurement on each of both legs of 21 volunteers.

  During the procedure which should last about 10 min/patient

Secondary Outcomes (4)

• Intra-operator reproducibility

  During the procedure which should last about 10 min/patient

• Participant's reported pain: baseline

  Before (5 min before procedure).

• Participant's reported pain: at highest externally applied pressure

  During the procedure (the procedure will last about 10 min/patient)

• Participant's reported pain: after the procedure

  Immediately after procedure (no follow up is planned)

Other Outcomes (3)

• Assessment of adverse events

  During the procedure which should last about 10 min/patient

• Assessment of device deficiencies

  During the procedure which should last about 10 min/patient

• New risk identification

  Within 12 hours after procedure (no follow up is planned)

Study Arms (1)

CPM#1

EXPERIMENTAL

Compartment compressibility ratio measurement using the CPM#1 device

Device: Measurement of compartment compressibility

Interventions

Measurement of compartment compressibility DEVICE

Application of the CPM#1 device for compartment compressibility ratio measurement - 4 measurements on both legs of each healthy volunteer will be performed

CPM#1

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Compremium AG: lead

Study Sites (1)

Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Helen Anwander, Dr. med.

  Department für Orthopädie und Traumatologie, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigators will be blinded to the measurement results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 10, 2022
• Study Start: May 4, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)