Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

Liver Transplant; Complications Clinical Trial

— NIRS_GREFFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945942
• Other study ID #: 2018/07NOV/413
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: March 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Liver Transplant; Complications

Intervention

Device:
• Near infrared spectroscopy with INVOS device
somatic and cerebral oximetry by INVOS in pediatric liver transplantation
• Near infrared spectroscopy with Foresight device
somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	influence of chromophores such as bilirubin on oximetry values provided by two different devices	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)