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Completed

NCT Number: NCT01452425

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

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.

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Key information

Conditions

Human Volunteers

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tourniquet

Device

Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion

INVOS assessment

Device

Near Infraread spectroscopy, non invasive

EMG assessment

Device

Electromyography, non invasive

Primary outcomes

  1. 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.

    Measures were:

    [mean (SD)] INVOS (in %) value at baseline and at the time of the block

  2. Intracompartmental Pressure (ICP)

    Time frame: 45 minutes

    [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2011
Registry last updated
Dec 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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