search
Back to results

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

Primary Purpose

Human Volunteers

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Tourniquet
INVOS assessment
EMG assessment
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Human Volunteers focused on measuring Human volunteers

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • >18yr
  • Informed consent
  • Male

Exclusion Criteria:

  • Neuropathies
  • Vascular pathology
  • Actual pain
  • Anti-platelet or anticoagulant therapy
  • Ipsilateral history of fracture

Sites / Locations

  • Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tourniquet

Arm Description

Inflation of a tourniquet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
December 15, 2014
Sponsor
Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT01452425
Brief Title
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
Official Title
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Volunteers
Keywords
Human volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tourniquet
Arm Type
Experimental
Arm Description
Inflation of a tourniquet
Intervention Type
Device
Intervention Name(s)
Tourniquet
Intervention Description
Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
Intervention Type
Device
Intervention Name(s)
INVOS assessment
Intervention Description
Near Infraread spectroscopy, non invasive
Intervention Type
Device
Intervention Name(s)
EMG assessment
Intervention Description
Electromyography, non invasive
Primary Outcome Measure Information:
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
Title
Intracompartmental Pressure (ICP)
Description
[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block
Time Frame
45 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Forget, M.D.
Organizational Affiliation
UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs