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

NCT ID: NCT01452425

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Human Volunteers

Keywords

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Human volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tourniquet

Inflation of a tourniquet

Group Type EXPERIMENTAL

Tourniquet

Intervention Type DEVICE

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

INVOS assessment

Intervention Type DEVICE

Near Infraread spectroscopy, non invasive

EMG assessment

Intervention Type DEVICE

Electromyography, non invasive

Interventions

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Tourniquet

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

Intervention Type DEVICE

INVOS assessment

Near Infraread spectroscopy, non invasive

Intervention Type DEVICE

EMG assessment

Electromyography, non invasive

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* \>18yr
* Informed consent
* Male

Exclusion Criteria

* Neuropathies
* Vascular pathology
* Actual pain
* Anti-platelet or anticoagulant therapy
* Ipsilateral history of fracture
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Forget Patrice

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrice Forget, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B40320107753

Identifier Type: -

Identifier Source: org_study_id