Status:
COMPLETED
Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation
Lead Sponsor:
Advanced Perfusion Diagnostics
Collaborating Sponsors:
CEISO
Conditions:
Multiple Organ Dysfunction Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs...
Eligibility Criteria
Inclusion
- 18 years of age or more,
- Male or female,
- ICU patient, on vasoactive amines, under mechanical ventilation,
- Stable hemodynamic status,
- Life expectancy expected to exceed 72 hours,
- Length of ICU stay greater than 5 days,
- Willing to participate and signed informed consent,
- Affiliation to the French social security system.
Exclusion
- Pregnant or lactating woman,
- Ongoing enteral nutrition,
- Risk of gastrointestinal ischemia,
- History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area,
- Known ear-nose-throat malignant disease,
- Unexplored dysphagia,
- Known recent gastrointestinal suture,
- Esophageal varices,
- Abdominal pain,
- Unstable cervical fracture,
- Moribund patient,
- Active participation in another investigational protocol within the past 30 days,
- Subject legally protected, under legal guardianship, deprived of his/her liberty by judicial or administrative decision.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02246036
Start Date
December 1 2014
End Date
September 1 2016
Last Update
October 13 2016
Active Locations (3)
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1
CHU Estaing - Service réanimation adultes
Clermont-Ferrand, France, 63003
2
Centre Hospitalier Lyon-Sud
Lyon, France, 69310
3
GHU Caremeau - Unité REA
Nîmes, France, 30900