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In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome

U

Université Catholique de Louvain

Status and phase

Completed
Phase 1

Conditions

Human Volunteers

Treatments

Device: EMG assessment
Device: Tourniquet
Device: INVOS assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT01452425
B40320107753

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers
  • >18yr
  • Informed consent
  • Male

Exclusion criteria

  • Neuropathies
  • Vascular pathology
  • Actual pain
  • Anti-platelet or anticoagulant therapy
  • Ipsilateral history of fracture

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Tourniquet
Experimental group
Description:
Inflation of a tourniquet
Treatment:
Device: EMG assessment
Device: Tourniquet
Device: INVOS assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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