In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
|ClinicalTrials.gov Identifier: NCT01452425|
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Volunteers||Device: Tourniquet Device: INVOS assessment Device: EMG assessment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.|
|Study Start Date :||October 2011|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Inflation of a tourniquet
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusionDevice: INVOS assessment
Near Infraread spectroscopy, non invasiveDevice: EMG assessment
Electromyography, non invasive
- Comparison Between INVOS Monitoring and Electromyography [ Time Frame: 45 minutes ]
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.
[mean (SD)] INVOS (in %) value at baseline and at the time of the block
- Intracompartmental Pressure (ICP) [ Time Frame: 45 minutes ][mean (SD)] ICP (in mmHg), value at baseline and at the time of the block
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452425
|Cliniques universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Principal Investigator:||Patrice Forget, M.D.||UCL|