Human Volunteers
Conditions
Keywords
Human volunteers
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.
Detailed description
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.
Interventions
DEVICETourniquet
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
DEVICEINVOS assessment
Near Infraread spectroscopy, non invasive
DEVICEEMG assessment
Electromyography, non invasive
Sponsors
Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * \>18yr * Informed consent * Male
Exclusion criteria
* Neuropathies * Vascular pathology * Actual pain * Anti-platelet or anticoagulant therapy * Ipsilateral history of fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison Between INVOS Monitoring and Electromyography | 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. Measures were: \[mean (SD)\] INVOS (in %) value at baseline and at the time of the block |
| Intracompartmental Pressure (ICP) | 45 minutes | \[mean (SD)\] ICP (in mmHg), value at baseline and at the time of the block |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tourniquet No adverse event | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Tourniquet |
|---|---|
| Age, Customized age | 33 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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
Time frame: 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tourniquet | Comparison Between INVOS Monitoring and Electromyography | INVOS (Baseline) | 73 % of StcO2 | Standard Deviation 9 |
| Tourniquet | Comparison Between INVOS Monitoring and Electromyography | INVOS (At time of the block) | 46 % of StcO2 | Standard Deviation 11 |
Primary
Intracompartmental Pressure (ICP)
\[mean (SD)\] ICP (in mmHg), value at baseline and at the time of the block
Time frame: 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tourniquet | Intracompartmental Pressure (ICP) | ICP (Baseline) | 17 mmHg | Standard Deviation 9 |
| Tourniquet | Intracompartmental Pressure (ICP) | ICP (At time of the block) | 70 mmHg | Standard Deviation 6 |