Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

NCT02246036 | Completed

• 1 other identifier: 2014-A00989-38
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Organ Dysfunction Syndrome

Outcome Measures

Primary Outcomes (1)

• Absence of duodenal lesions

  Duodenal lesions are defined as visible alterations of the duodenum.

  24 hours

Secondary Outcomes (1)

• Signal-to-noise ratio of the APD probe

  24 hours

Study Arms (1)

APD probe

EXPERIMENTAL

Placement of a duodenal probe during 24 hours.

Device: APD probe

Interventions

APD probe DEVICE

The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).

APD probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Perfusion Diagnostics: lead
• CEISO: collaborator

Study Sites (3)

CHU Estaing - Service réanimation adultes

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Lyon-Sud

Lyon, 69310, France

Location

GHU Caremeau - Unité REA

Nîmes, 30900, France

Location

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernard Allaouchiche, Prof.

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 22, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

FR (3)