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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
Sponsor:
Collaborator:
CEISO
Information provided by (Responsible Party):
Advanced Perfusion Diagnostics

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.


Condition or disease Intervention/treatment Phase
Multiple Organ Dysfunction Syndrome Device: APD probe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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).




Primary Outcome Measures :
  1. Absence of duodenal lesions [ Time Frame: 24 hours ]
    Duodenal lesions are defined as visible alterations of the duodenum.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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France
CHU Estaing - Service réanimation adultes
Clermont-ferrand, France, 63003
Centre Hospitalier Lyon-Sud
Lyon, France, 69310
GHU Caremeau - Unité REA
Nimes, France, 30900
Sponsors and Collaborators
Advanced Perfusion Diagnostics
CEISO
Investigators
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Principal Investigator: Bernard Allaouchiche, Prof. Hospices Civils de Lyon

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Responsible Party: Advanced Perfusion Diagnostics
ClinicalTrials.gov Identifier: NCT02246036     History of Changes
Other Study ID Numbers: 2014-A00989-38
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Multiple Organ Failure
Shock
Pathologic Processes