Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation (MC Monitor)
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|ClinicalTrials.gov Identifier: NCT02246036|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : October 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Organ Dysfunction Syndrome||Device: APD probe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: APD probe
Placement of a duodenal probe during 24 hours.
Device: APD probe
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).
- Absence of duodenal lesions [ Time Frame: 24 hours ]Duodenal lesions are defined as visible alterations of the duodenum.
- Signal-to-noise ratio of the APD probe [ Time Frame: 24 hours ]The signal is a reflect of the pulsatile flow in the duodenum. This assertion is evaluated thanks to a signal-to-noise ratio of the cardiac frequency in the PPG on other non-filtered signal componants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246036
|CHU Estaing - Service réanimation adultes|
|Clermont-ferrand, France, 63003|
|Centre Hospitalier Lyon-Sud|
|Lyon, France, 69310|
|GHU Caremeau - Unité REA|
|Nimes, France, 30900|
|Principal Investigator:||Bernard Allaouchiche, Prof.||Hospices Civils de Lyon|