Tolerance and Safety of a Duodenal Probe Monitoring the M... | NCT02246036

Studies
Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

NCT02246036

Sponsor

Advanced Perfusion Diagnostics

Status

Completed

Last Update Posted

Oct 13, 2016Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Multiple Organ Dysfunction Syndrome

Interventions

APD probe

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Name	Class
CEISO	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
APD probe	Experimental	Placement of a duodenal probe during 24 hours.	Device: APD probe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).	APD probe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of duodenal lesions	Duodenal lesions are defined as visible alterations of the duodenum.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Allaouchiche, Prof.	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Estaing - Service réanimation adultes		Clermont-Ferrand		63003	France
Centre Hospitalier Lyon-Sud

Condition Browse Module

MeSH Terms

ID	Term
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D012769	Shock
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided