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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Forget Patrice, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01452425
First received: October 11, 2011
Last updated: October 14, 2011
Last verified: October 2011
  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
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.


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: December 2011
Estimated 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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452425

Contacts
Contact: Patrice Forget, M.D. +3227641821 forgetpatrice@yahoo.fr

Locations
Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Patrice Forget, M.D.    +3227641821    forgetpatrice@yahoo.fr   
Principal Investigator: Patrice Forget, M.D.         
Sponsors and Collaborators
Université Catholique de Louvain
Investigators
Principal Investigator: Patrice Forget, M.D. UCL
  More Information

No publications provided

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
Last Updated: October 14, 2011
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 26, 2014