Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

NCT ID: NCT03945942

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2020-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplant; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric liver transplant patients

Using somatic and cerebral Near infrared spectroscopy devices

Group Type OTHER

Near infrared spectroscopy with INVOS device

Intervention Type DEVICE

somatic and cerebral oximetry by INVOS in pediatric liver transplantation

Near infrared spectroscopy with Foresight device

Intervention Type DEVICE

somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Near infrared spectroscopy with INVOS device

somatic and cerebral oximetry by INVOS in pediatric liver transplantation

Intervention Type DEVICE

Near infrared spectroscopy with Foresight device

somatic and cerebral oximetry with Foresight device in pediatric liver transplantation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Natalia MAGASICH-AIROLA, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/07NOV/413

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.