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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01452425
First received: October 11, 2011
Last updated: December 15, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Human Volunteers
Device: Tourniquet
Device: INVOS assessment
Device: EMG assessment
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.

Resource links provided by NLM:


Further study details as provided by Université Catholique de Louvain:

Primary Outcome Measures:
  • Comparison Between INVOS Monitoring and Electromyography [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block


Enrollment: 10
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Forget Patrice, MD, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01452425     History of Changes
Other Study ID Numbers: B40320107753 
Study First Received: October 11, 2011
Results First Received: December 1, 2014
Last Updated: December 15, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by Université Catholique de Louvain:
Human volunteers

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

ClinicalTrials.gov processed this record on August 25, 2016