Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices (NIRS_GREFFE)

March 17, 2021 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation

Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
  • Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure

Exclusion Criteria:

  • refusal of the patient or his parents to consent
  • known brain or Neurological pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pediatric liver transplant patients
Using somatic and cerebral Near infrared spectroscopy devices
Device: Near infrared spectroscopy with INVOS device
somatic and cerebral oximetry by INVOS in pediatric liver transplantation
Device: Near infrared spectroscopy with Foresight device
somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
influence of chromophores such as bilirubin on oximetry values provided by two different devices
Time Frame: From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)
measure of oximetry values by two different devices at different time points in function of serum bilirubin levels
From Day 0 of surgery until arrival at pediatric intensive care unit (up to 12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Natalia MAGASICH-AIROLA, MD, natalia.magasich@uclouvain.be

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

October 15, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/07NOV/413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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