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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.
After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tourniquet | Experimental | Inflation of a tourniquet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tourniquet | Device | Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Forget, M.D. | UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tourniquet | Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tourniquet | No adverse event |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | % of StcO2 | 45 minutes |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tourniquet | No adverse event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Patrice Forget | UCLouvain | 3227641821 | forgetpatrice@yahoo.fr |
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| ID | Term |
|---|---|
| D014111 | Tourniquets |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| INVOS assessment | Device | Near Infraread spectroscopy, non invasive |
|
| EMG assessment | Device | Electromyography, non invasive |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Intracompartmental Pressure (ICP) | [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block | Posted | Mean | Standard Deviation | mmHg | 45 minutes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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