Evaluation of the Urethral Photoplethysmography-derived Perfusion Device (IKORUS) in Patients Undergoing Major Abdominal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Technology
- Sponsor
- Erasme University Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Analysis of uPi evolution during surgery and comparison with Stroke volume
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital
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%
Outcomes
Primary Outcomes
Analysis of uPi evolution during surgery and comparison with Stroke volume
Time Frame: 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 Outcomes
- Occurrence of decreased perfusion during surgery(during surgery)