CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Tourniquet +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01452425
NCT01452425Phase 1Completed
CompareCT.gov

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

Université Catholique de Louvain·interventional·Posted Oct 14, 2011·Updated Dec 22, 2014

In Brief

A Phase 1 clinical trial evaluating Tourniquet, INVOS assessment, and 1 other intervention for Human Volunteers. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Volunteers
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.7 years ago

Interventions

Tourniquetdevice

Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion

INVOS assessmentdevice

Near Infraread spectroscopy, non invasive

EMG assessmentdevice

Electromyography, non invasive