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

Human Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452425
• Other study ID #: B40320107753
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2011
• Last updated: December 15, 2014
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Compartment Syndromes
• Human Volunteers

Intervention

Device:
• Tourniquet
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
• INVOS assessment
Near Infraread spectroscopy, non invasive
• EMG assessment
Electromyography, non invasive

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Intracompartmental Pressure (ICP)	[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block	45 minutes	Yes