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Completed

NCT Number: NCT04187274

Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery

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.

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Key information

Conditions

Technology

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme Hospital

Brussels, Brussel-hoofdstad, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Occurrence of decreased perfusion during surgery

    Time frame: during surgery

    Occurrence of decreased perfusion during surgery

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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