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Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03945942
Acronym
NIRS_GREFFE
Enrollment
33
Registered
2019-05-10
Start date
2019-03-15
Completion date
2020-10-15
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications

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.

Interventions

DEVICENear infrared spectroscopy with INVOS device

somatic and cerebral oximetry by INVOS in pediatric liver transplantation

DEVICENear infrared spectroscopy with Foresight device

somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
influence of chromophores such as bilirubin on oximetry values provided by two different devicesFrom 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026