Phase 1 N=10 Basic Science

In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome

Human Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01452425 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Comparison Between INVOS Monitoring and Electromyography — 73; 46 % of StcO2

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tourniquet (Device); INVOS assessment (Device); EMG assessment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Université Catholique de Louvain
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison Between INVOS Monitoring and Electromyography	73; 46	—
PRIMARY Intracompartmental Pressure (ICP)	17; 70	—

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.

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

View full record on ClinicalTrials.gov →

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.