Multi-center Isoelectric EEG Study in Children Under General Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Anesthesia; General Anesthesia; Electroencephalography

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.

• Study Type: Observational
• Enrollment (Actual): 687

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Children's Hospital at Westmead
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital (RCH, Melbourne, Australia)
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Princess Margaret Hospital for Children (PMH, Perth, Australia)
• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital/Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510620
      • Guangzhou Women And Children's Medical Center
  • Liaoning
    • Shenyang, Liaoning, China, 110003
      • Shengjing Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University, China
    • Chengdu, Sichuan, China, 610071
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus MC Sophia Children's Hospital
• Switzerland
  • Geneva, Switzerland
    • University of Geneva
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

0-36 month old children undergoing general anesthesia for surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children: 0-36mo; 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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Erasmus Medical Center; University of Texas Southwestern Medical Center; Children's Hospital Medical Center, Cincinnati; West China Hospital; Shengjing Hospital; Sydney Children's Hospitals Network; Royal Children's Hospital; Shanghai Children's Medical Center; Beijing Children's Hospital; University of Geneva, Switzerland; Sichuan Provincial People's Hospital; Guangzhou Women and Children's Medical Center; Yuying Children's Hospital of Wenzhou Medical University; Princess Margaret Hospital for Children
• Investigators: Study Director: Paula Hu, Clinical Research Manager; Principal Investigator: Justin Skowno, Sydney Children's Hospitals Network; Principal Investigator: Andrew J Davidson, Royal Children's Hospital, Melbourne, Australia; Principal Investigator: Britta Regli-von Ungern-Sternberg, Princess Margaret Hospital for Children, Perth, Australia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2018
• Primary Completion (ACTUAL): December 13, 2019
• Study Completion (ACTUAL): February 27, 2020

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: EEG; Electroencephalography; Pediatric anesthesia
• Other Study ID Numbers: 17-014608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Coded limited dataset with minimum necessary protected health information (PHI) such as dates will be shared with Masimo and statisticians for EEG interpretation and data analysis.
• IPD Sharing Time Frame: Limited dataset will be available to other researchers for up to 2 years after end of study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No