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Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

  • Clinicaltrials.gov identifier

    NCT03945942

  • Recruitment Status

    Completed

  • First Posted

    May 10, 2019

  • Last update posted

    March 18, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Liver Transplant; Complications
  • Intervention/Treatment: Device: Near infrared spectroscopy with INVOS device
    Device: Near infrared spectroscopy with Foresight device
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 33 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Influence of Hyperbilirubinaemia on Foresight and INVOS Oximetry Values in Pediatric Hepatic Transplantation
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: October 2020
  • Actual Study Completion Date: October 2020

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. 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

Eligibility Criteria

  • Ages Eligible for Study: up to 18 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Locations

Belgium
Cliniques Universitaires Saint-Luc
Brussels

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

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

More Information

  • Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • ClinicalTrials.gov Identifier: NCT03945942 History of Changes
  • Other Study ID Numbers: 2018/07NOV/413
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: March 18, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hyperbilirubinemia