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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452425
Other study ID # B40320107753
Secondary ID
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


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
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