NCT04187274

Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

Evaluation of the Urethral Photoplethysmography-derived Perfusion Device (IKORUS) in Patients Undergoing Major Abdominal Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Technology

Interventions

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

Timeline

• Start date: 2019-09-04
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2019-12-05
• Last updated: 2020-09-22

Locations

1 site across 1 country: Belgium