Human Volunteers Clinical Trial
Official title:
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
Verified date | December 2014 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers - >18yr - Informed consent - Male Exclusion Criteria: - Neuropathies - Vascular pathology - Actual pain - Anti-platelet or anticoagulant therapy - Ipsilateral history of fracture |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint-Luc | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison Between INVOS Monitoring and Electromyography | A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: [mean (SD)] INVOS (in %) value at baseline and at the time of the block |
45 minutes | Yes |
Primary | Intracompartmental Pressure (ICP) | [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block | 45 minutes | Yes |
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