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

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ClinicalTrials.gov Identifier: NCT01452425
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Human Volunteers Device: Tourniquet Device: INVOS assessment Device: EMG assessment Phase 1

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.

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tourniquet
Inflation of a tourniquet
Device: Tourniquet
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Device: INVOS assessment
Near Infraread spectroscopy, non invasive
Device: EMG assessment
Electromyography, non invasive



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
Principal Investigator: Patrice Forget, M.D. UCL

Responsible Party: Forget Patrice, MD, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01452425     History of Changes
Other Study ID Numbers: B40320107753
First Posted: October 14, 2011    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014
Last Verified: December 2014

Keywords provided by Forget Patrice, Université Catholique de Louvain:
Human volunteers

Additional relevant MeSH terms:
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases