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

Primary Purpose

Multiple Organ Dysfunction Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
APD probe
Sponsored by
Advanced Perfusion Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Organ Dysfunction Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Estaing - Service réanimation adultes
  • Centre Hospitalier Lyon-Sud
  • GHU Caremeau - Unité REA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APD probe

Arm Description

Placement of a duodenal probe during 24 hours.

Outcomes

Primary Outcome Measures

Absence of duodenal lesions
Duodenal lesions are defined as visible alterations of the duodenum.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2014
Last Updated
October 12, 2016
Sponsor
Advanced Perfusion Diagnostics
Collaborators
CEISO
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1. Study Identification

Unique Protocol Identification Number
NCT02246036
Brief Title
Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation
Acronym
MC Monitor
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Perfusion Diagnostics
Collaborators
CEISO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Organ Dysfunction Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APD probe
Arm Type
Experimental
Arm Description
Placement of a duodenal probe during 24 hours.
Intervention Type
Device
Intervention Name(s)
APD probe
Intervention Description
The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).
Primary Outcome Measure Information:
Title
Absence of duodenal lesions
Description
Duodenal lesions are defined as visible alterations of the duodenum.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Signal-to-noise ratio of the APD probe
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Allaouchiche, Prof.
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Estaing - Service réanimation adultes
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Name
GHU Caremeau - Unité REA
City
Nimes
ZIP/Postal Code
30900
Country
France

12. IPD Sharing Statement

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Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

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