Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

Not Applicable

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Device: Near infrared spectroscopy with INVOS device; Device: Near infrared spectroscopy with Foresight device

• Registration Number: NCT03945942
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-03-04
• Study Start: 2019-03-15
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric liver transplant patients	Near infrared spectroscopy with INVOS device	Using somatic and cerebral Near infrared spectroscopy devices
Pediatric liver transplant patients	Near infrared spectroscopy with Foresight device	Using somatic and cerebral Near infrared spectroscopy devices

Primary Outcome Measures

Name	Time	Method
influence of chromophores such as bilirubin on oximetry values provided by two different devices	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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium