Recruitment

Recruitment Status
Completed
Estimated Enrollment
1125

Summary

Conditions
  • Electroencephalography
  • General Anesthesia
  • Pediatric Anesthesia
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Younger than 36 years
Gender
Both males and females

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, medi...

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.

Tracking Information

NCT #
NCT03432351
Collaborators
  • Royal Children's Hospital
  • Sydney Children's Hospitals Network
  • Princess Margaret Hospital for Children
  • Guangzhou Women and Children's Medical Center
  • Yuying Children's Hospital of Wenzhou Medical University
  • Sichuan Provincial People's Hospital
  • University of Texas Southwestern Medical Center
  • Beijing Children's Hospital
  • Erasmus Medical Center
  • Shanghai Children's Medical Center
  • Shengjing Hospital
  • West China Hospital
  • University of Geneva, Switzerland
  • Children's Hospital Medical Center, Cincinnati
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