IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE). (IBIS)
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.
調査の概要
状態
詳細な説明
There is currently no available data on the reliability of processed electroencephalogram (pEEG) for adequately predicting depth of anaesthesia (DOA) with abnormal electroencephalogram (EEG) and those on anticonvulsant medication. Examples of epilepsy syndromes in which seizures and abnormal EEG (abnormal backgrounds: including excess discontinuity, excess slow, low amplitude, lack of sleep stages, and frequent epileptiform discharges) are predominant features are Early Infantile Developmental and Epileptic Encephalopathy (EIDEE), Epilepsy of infancy with Migrating Focal Seizures (EIMFS), Infantile Spasm Syndrome (IS) and other Epileptic encephalopathies (EE) and Developmental and Epileptic Encephalopathy (DEE). Considering the use of pEEG is common in paediatric anaesthesia and one of the strategies used to precent awareness and excessive anaesthesia provision, it would be pertinent to examine whether pEEG values truly reflect depth of sedation of these infants or if they are artificially low or high. To this end, investigators aim to concurrently measure EEG and pEEG patterns in infants with DEEs with onset in infancy and early childhood. Both pEEG patterns and their values will be measured with two commonly used monitors- the BiSpectral Index (BIS) and Sedline. Data from both pEEG monitors can then be directly compared with contemporaneous conventional EEG patterns on each patient.
This study will be conducted in collaboration with paediatric anaesthetists and neurologists in Perth Children's Hospital, Western Australia and the Hospital das Clínicas, Faculty of Medicine, University of São Paulo, Brazil. The target sample size is 40 participants- 20 from each centre. Participants will be invited to visit the hospital. Each awake participant will be fitted with a 16-lead EEG and additionally a BIS or Sedline monitor, applied consecutively in random order. The measurement period will be 30 minutes for each of the BIS and the Sedline with continuous EEG assessment throughout. This will allow the pEEG data to be measured against a corresponding continuous EEG.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Britta S von Ungern-Sternberg, MD, PhD
- 電話番号：+61 8 6456 4806
- メール：britta.regli-vonungern@health.wa.gov.au
研究場所
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Western Australia
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Perth、Western Australia、オーストラリア、6909
- Perth Children's Hospital
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コンタクト：
- Britta S von Ungern-Sternberg, MD, PhD
- 電話番号：+61 8 6456 4806
- メール：britta.regli-vonungern@health.wa.gov.au
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コンタクト：
- Lliana Slevin, BSc
- 電話番号：+61 426 952 977
- メール：lliana.slevin@thekids.org.au
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São Paulo、ブラジル
- Hospital das Clinicas, São Paulo, Sao Paulo
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コンタクト：
- Vinícius Quintão, MD PHD
- 電話番号：+55 11 2661 5795
- メール：vinicius.quintao@hc.fm.usp.br
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Children (<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).
Exclusion Criteria:
- Language barriers impeding data collection
- Department for Child Protection and Family Support is involved in the care of the child.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause
Children (<16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years).
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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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Compare pEEG values in awake patients with developmental and epileptic encephalopathies
時間枠：60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.
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pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.
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60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RGS0000008394
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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