Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation (MC Monitor)

Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.

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.

Study Overview

• Status: Completed
• Conditions: Multiple Organ Dysfunction Syndrome
• Intervention / Treatment: Device: APD probe

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63003
    • CHU Estaing - Service réanimation adultes
  • Lyon, France, 69310
    • Centre Hospitalier Lyon-Sud
  • Nimes, France, 30900
    • GHU Caremeau - Unité REA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of duodenal lesions	Duodenal lesions are defined as visible alterations of the duodenum.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal-to-noise ratio of the APD probe	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.	24 hours

Collaborators and Investigators

• Sponsor: Advanced Perfusion Diagnostics
• Collaborators: CEISO
• Investigators: Principal Investigator: Bernard Allaouchiche, Prof., Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: 2014-A00989-38