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Completed

NCT Number: NCT05367921

SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1

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.

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Key information

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Inter-operator reproducibility with 3 raters

    Time frame: During the procedure which should last about 10 min/patient

    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.

Secondary outcomes

  1. Intra-operator reproducibility

    Time frame: During the procedure which should last about 10 min/patient

    Intra-operator reproducibility will be assessed using intra-class correlation coefficients (two-way mixed effects, single measurement, absolute agreement). One of the three independent raters will conduct two measurements on 42 legs (21 volunteers).

  2. Participant's reported pain: baseline

    Time frame: Before (5 min before procedure).

    Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.

  3. Participant's reported pain: at highest externally applied pressure

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

    Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.

  4. Participant's reported pain: after the procedure

    Time frame: Immediately after procedure (no follow up is planned)

    Participant's reported pain will be assessed using a 0-100mm Visual Analogue Scale (VAS) at specific time points.

Other outcomes

  1. Assessment of adverse events

    Time frame: During the procedure which should last about 10 min/patient

    Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants).

  2. Assessment of device deficiencies

    Time frame: During the procedure which should last about 10 min/patient

    Safety of the procedure will be assessed by documenting device deficiencies (description)

  3. New risk identification

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

    Practitioner will be asked to identify risk due to the application of the device in patient care.

Sponsors and collaborators

Lead sponsor

Compremium AG

Industry

Registry information

Official study title

Clinical Validation of CPM#1 Compression Ratio Measurement on Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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