Clinical trial NCT02246036: Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation
Official title: Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Organ Dysfunction Syndrome
Lead sponsor: Advanced Perfusion Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2014-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.

Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).

"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.

The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.

The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Absence of duodenal lesions
timeFrame: 24 hours
Secondary outcomes:
measure: Signal-to-noise ratio of the APD probe
timeFrame: 24 hours
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU Estaing - Service réanimation adultes
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Nimes
country: France
facility: GHU Caremeau - Unité REA
Study officials:
affiliation: Hospices Civils de Lyon
name: Bernard Allaouchiche, Prof.
role: PRINCIPAL_INVESTIGATOR
References: