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Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

NCT02246036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-10-13

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Advanced Perfusion Diagnostics

    lead INDUSTRY

Principal Investigators

  • Bernard Allaouchiche, Prof. · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246036 on ClinicalTrials.gov