In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||December 2011|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|