IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-15
SponsorTelethon Kids Institute

About this trial

When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.

Children with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children (<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).

Disqualifiers

Language barriers impeding data collection

Department for Child Protection and Family Support is involved in the care of the child.

Trial population

20 eligible patients identified by the neurology department at Perth Children's Hospital and 20 eligible patients identified by the neurology department at Hospital das Clinicas HCFMUSP, Faculdade de Medicina, will be approached for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.

    Diagnostic test

    This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG. The depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause1 intervention

Trial outcomes

Primary outcomes

1

Compare pEEG values in awake patients with developmental and epileptic encephalopathies

pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.

Time frame
60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Telethon Kids Institute

Lead sponsor

Child and Adolescent Health Service - Perth

Collaborator

Feculdade de Medicina da Universidade de Sao Paulo - Brasil

Collaborator

University of Sao Paulo General Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: