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

• Sponsor: Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT01452425
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Volunteers	Device: Tourniquet; Device: INVOS assessment; Device: EMG assessment	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Intracompartmental Pressure (ICP) [45 minutes]

   [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Université Catholique de Louvain

Investigators

• Principal Investigator: Patrice Forget, M.D., UCL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Forget Patrice, MD, Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT01452425
• Other Study ID Numbers: B40320107753
• First Posted: Oct 14, 2011
• Last Update Posted: Dec 22, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Forget Patrice, MD, Université Catholique de Louvain: Human volunteers
• Additional relevant MeSH terms: Compartment Syndromes

Study Results

Participant Flow

Arm/Group Title	Tourniquet
Arm/Group Description	Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Tourniquet
Arm/Group Description	No adverse event
Overall Participants	10
Age, Customized (years) [Mean (Standard Deviation) ]
age	33 (4)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%

Outcome Measures

1. Primary Outcome

Title	Comparison Between INVOS Monitoring and Electromyography
Description	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
Time Frame	45 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tourniquet
Arm/Group Description	Inflation of a tourniquet Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Measure Participants	10
INVOS (Baseline)	73 (9)
INVOS (At time of the block)	46 (11)

2. Primary Outcome

Title	Intracompartmental Pressure (ICP)
Description	[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block
Time Frame	45 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tourniquet
Arm/Group Description
Measure Participants	10
ICP (Baseline)	17 (9)
ICP (At time of the block)	70 (6)

Adverse Events

Arm/Group Title	Tourniquet
Arm/Group Description	No adverse event
All Cause Mortality
	Tourniquet
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Tourniquet
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Tourniquet
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.