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Completed

NCT Number: NCT02246036

Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

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.

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Key information

Conditions

Multiple Organ Dysfunction Syndrome Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Estaing - Service réanimation adultes, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Absence of duodenal lesions

    Time frame: 24 hours

    Duodenal lesions are defined as visible alterations of the duodenum.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Advanced Perfusion Diagnostics

Industry

Collaborators

  • CEISO

Registry information

Official study title

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

Acronym: MC Monitor

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2014
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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