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Completed

NCT Number: NCT03945942

Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

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

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Key information

Conditions

Liver Transplant; Complications

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Near infrared spectroscopy with INVOS device

Device

somatic and cerebral oximetry by INVOS in pediatric liver transplantation

Near infrared spectroscopy with Foresight device

Device

somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: NIRS_GREFFE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 10, 2019
Registry last updated
Mar 18, 2021

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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