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

Phase 1

Completed

• Conditions: Human Volunteers
• Interventions: Device: Tourniquet; Device: INVOS assessment; Device: EMG assessment

• Registration Number: NCT01452425
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

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

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-01
• Results First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Results First Posted: 2014-12-22
• Last Update Posted: 2014-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tourniquet	EMG assessment	Inflation of a tourniquet
Tourniquet	Tourniquet	Inflation of a tourniquet
Tourniquet	INVOS assessment	Inflation of a tourniquet

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium