Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

Multiple Organ Dysfunction Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246036
• Other study ID #: 2014-A00989-38
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: October 12, 2016
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Advanced Perfusion Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure

Intervention

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).

Locations

Country	Name	City	State
France	CHU Estaing - Service réanimation adultes	Clermont-ferrand
France	Centre Hospitalier Lyon-Sud	Lyon
France	GHU Caremeau - Unité REA	Nimes

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Perfusion Diagnostics	CEISO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of duodenal lesions	Duodenal lesions are defined as visible alterations of the duodenum.	24 hours	Yes
Secondary	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.	24 hours	No