Phase 1
Completed N=10
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
Human Volunteers
Source: ClinicalTrials.gov NCT01452425 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Comparison Between INVOS Monitoring and Electromyography — 73; 46 % of StcO2
Summary
Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication.
The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively.
The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison Between INVOS Monitoring and Electromyography |
73; 46 | — |
| PRIMARY Intracompartmental Pressure (ICP) |
17; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
- >18yr
- Informed consent
- Male
Exclusion Criteria
- Neuropathies
- Vascular pathology
- Actual pain
- Anti-platelet or anticoagulant therapy
- Ipsilateral history of fracture
Data sourced from ClinicalTrials.gov (NCT01452425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.