Evaluation of the IKORUS Technology in Patients Undergoin... | NCT04187274

Studies
Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

NCT04187274

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Sep 22, 2020Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Technology

Interventions

IKORUS technology

Countries

Belgium

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

Sep 2020

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

Sep 4, 2019Actual

Primary Completion Date

Jul 30, 2020Actual

Completion Date

Jul 30, 2020Actual

First Submitted Date

Dec 1, 2019

First Submission Date that Met QC Criteria

Dec 3, 2019

First Posted Date

Dec 5, 2019Actual

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

Sep 18, 2020

Last Update Posted Date

Sep 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Joosten, MD PhD, Principal Investigator, Erasme University HospitalPrincipal Investigator

Lead Sponsor

Erasme University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The goal of this observational substudy is to evaluate the feasibility, performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue perfusion device using urethral photoplethysmography in patients undergoing major abdominal surgery and in whom an advanced hemodynamic monitoring is placed.

Detailed Description

Continuous monitoring of tissue perfusion in patients undergoing major surgery remains challenging because of the lack of tools available. Through using urethral photoplethysmography, the urethral perfusion index (uPI) could allow tissue perfusion monitoring through a modified urinary catheter. The goal of this observational study is to evaluate the feasibility , performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new device in the field. We aimed to assess its performance (duration and signal quality), the uPI variations during hemodynamic events (fluid challenge) in patients undergoing major abdominal surgery and equipped with an advanced hemodynamic monitoring.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IKORUS technology	Device	Ikorus technology is a new micro perfusion device measuring via urethral photoplethysmography, the urethral perfusion index (uPI) in patients equipped with an urinary catheter.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of uPi evolution during surgery and comparison with Stroke volume	Percentage of case time with positive correlation between both variables (positive or negative) during a fluid challenge and during the whole case	during surgery

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of decreased perfusion during surgery	Occurrence of decreased perfusion during surgery	during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients undergoing major abdominal surgeries and equipped with an advanced hemodynamic monitoring for goal directed therapy

Exclusion Criteria:

Atrial fibrillation
Ejection fraction < 30%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing major abdominal surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JOOSTEN ALEXANDRE, MD PhD	ERASME	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme Hospital		Brussels	Brussel-hoofdstad	1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided