Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

Detailed Description
-----------------
Study will consist of placing a forehead EEG on the subject prior to induction of general anesthesia. EEG recording will continue until the end of anesthesia care. The anesthesiologist will be blinded to the EEG results during the study. Peri-operative factors such as demographics, vital signs, medications, etc... will also be recoded. Each site is expected to enroll up to 75 patients to provide at least 50 evaluable subjects. EEG files will be reviewed after recordings. After informed consent has been obtained, the subject will receive standard anesthetic care as administered by the anesthesia provider, who will be blinded to the EEG display and data. EEG recording will continue until the end of anesthesia care. After the recording, the EEG file will be reviewed and the number and duration of isoelectric events will be analyzed. Additional data that will be recorded include: patient demographic and perioperative factors (surgical procedure, anesthetic medications, end tidal anesthetic levels, induction and recovery room behavior, physiologic data, and time-stamps for intraoperative event. Post-operative questionnaire may also be sent to parents.

Official Title
-----------------
An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery

Conditions
-----------------
Electroencephalography, General Anesthesia, Pediatric Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0 to 36 (inclusive) months Greater than 36 weeks post-menstrual age (PMA) on the day of study Undergo general anesthesia for surgery that is expected to last more than 30 minutes (combined anesthesia and surgical time). Anesthetic maintenance with Sevoflurane if using volatile anesthetic or Propofol infusion if using total intravenous anesthetic. Expected airway management with a Laryngeal Mask Airway (LMA) or tracheal tube. Parental/legal guardian permission (informed consent) obtained Exclusion Criteria: American Society of Anesthesiology (ASA) (physical status) greater than 3 Structural/anatomical frontal brain malformations or other circumstances that make it difficult to apply the sensor to the forehead. History of abnormal EEG or severe neurological abnormalities. Scheduled for surgery above the neck, cardiac, brain, or emergency surgery. Known allergy or adverse reaction to ECG adhesives. On a sedative infusion (eg, propofol, morphine, fentanyl, midazolam, dexmedetomidine, ketamine) or recently on a sedative infusion (discontinued <24 hours ago) Received ketamine within 8 hours prior to the induction of general anesthesia

Ages Eligible for Study
-----------------
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children: 0-36mo<br>EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of isoelectric EEG events in young children. | Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels. | Up to 6 months after EEG recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuity of isoelectric EEG events among age groups | Patient age associated with isoelectric EEG events will be analyzed using a Pearson Chi square test to compare discontinuity of isoelectric EEG events among the age groups | Up to 12 months after EEG recording. | 
| Association of isoelectric EEG events between gender groups | Sample t-test or Wilcoxon rank-sum test, as appropriate will be used to analyze patient gender associated with isoelectric EEG events | Up to 12 months after EEG recording | 
| Patient Weight associated with isoelectric EEG events | Weight (kg) | Up to 12 months after EEG recording | 
| Changes in patient's physical status associated with isoelectric EEG events | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine any association between the patient's physical status outcome associated with isoelectric EEG events. | Up to 12 months after EEG recording | 
| Patient Gestational Age associated with isoelectric EEG events | Gestational Age (weeks) | Up to 12 months after EEG recording | 
| Procedure length associated with isoelectric EEG events | Procedure length (min) | Up to 12 months after EEG recording. | 
| Incidence of anesthetic type | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine incidence of anesthetic type (gas vs. TIVA) associated with isoelectric EEG events. | Up to 12 months after EEG recording. | 
| Anesthesia dose | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in anesthesia dose associated with isoelectric EEG events. | Up to 12 months after EEG recording. | 
| Heart rate associated with isoelectric EEG events | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in heart rate (beats per minute) associated with isoelectric EEG events. | Up to 12 months after EEG recording. | 
| Blood pressure associated with isoelectric EEG events | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in blood pressure (mmHg) associated with isoelectric EEG events. | Up to 12 months after EEG recording. | 
| End tidal carbon dioxide (CO2) associated with isoelectric EEG events. | Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in end tidal CO2 (mmHg) associated with isoelectric EEG events. | Up to 12 months after EEG recording. | 
| Anesthesia Recovery time associated with isoelectric EEG events. | Recovery time (min) | Up to 12 months after EEG recording. | 
| Changes in quality of life | The patient's parent or guardian will complete the PedsQL questionnaire, which measures pediatric quality of life. It consist of up to 45 questions for a total score ranging from 0 to 180. The lower the total score, the better the outcome. | Up to 2 months after EEG recording | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, Electroencephalography, Pediatric anesthesia