In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
2 months
October 11, 2011
December 1, 2014
December 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Intracompartmental Pressure (ICP)
\[mean (SD)\] ICP (in mmHg), value at baseline and at the time of the block
45 minutes
Study Arms (1)
Tourniquet
EXPERIMENTALInflation of a tourniquet
Interventions
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- \>18yr
- Informed consent
- Male
You may not qualify if:
- Neuropathies
- Vascular pathology
- Actual pain
- Anti-platelet or anticoagulant therapy
- Ipsilateral history of fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pr Patrice Forget
- Organization
- UCLouvain
Study Officials
- PRINCIPAL INVESTIGATOR
Patrice Forget, M.D.
UCL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 14, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 22, 2014
Results First Posted
December 22, 2014
Record last verified: 2014-12