Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

Completed

• Conditions: Technology

• Registration Number: NCT04187274
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Occurrence of decreased perfusion during surgery	during surgery	Occurrence of decreased perfusion during surgery

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Brussel-hoofdstad, Belgium