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 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
687
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
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.
Time frame: Up to 6 months after EEG recording
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
Time frame: 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
Time frame: Up to 12 months after EEG recording
Patient Weight associated with isoelectric EEG events
Weight (kg)
Time frame: 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.
Time frame: Up to 12 months after EEG recording
Patient Gestational Age associated with isoelectric EEG events
Gestational Age (weeks)
Time frame: Up to 12 months after EEG recording
Procedure length associated with isoelectric EEG events
Procedure length (min)
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Children's Medical Center Dallas
Dallas, Texas, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Royal Children's Hospital (RCH, Melbourne, Australia)
Parkville, Victoria, Australia
Princess Margaret Hospital for Children (PMH, Perth, Australia)
Subiaco, Western Australia, Australia
Beijing Children's Hospital/Capital Medical University
Beijing, Beijing Municipality, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
...and 5 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months after EEG recording.
Anesthesia Recovery time associated with isoelectric EEG events.
Recovery time (min)
Time frame: 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.
Time frame: Up to 2 months after EEG recording