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

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.

Study Overview

• Status: Completed
• Conditions: Human Volunteers
• Intervention / Treatment: Device: Tourniquet; Device: INVOS assessment; Device: EMG assessment

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
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Between INVOS Monitoring and Electromyography	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	45 minutes
Intracompartmental Pressure (ICP)	[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block	45 minutes

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Patrice Forget, M.D., UCL

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Human volunteers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes
• Other Study ID Numbers: B40320107753