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

This study is currently recruiting participants.

Verified October 2011 by Université Catholique de Louvain

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

History of Changes

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.

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

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 May 16, 2013

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