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| Name | Class |
|---|---|
| Sydney Children's Hospitals Network | OTHER |
| Royal Children's Hospital | OTHER |
| Princess Margaret Hospital for Children | OTHER |
| Guangzhou Women and Children's Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children: 0-36mo | EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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0-36 month old children undergoing general anesthesia for surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Paula Hu | Clinical Research Manager | Study Director |
| Justin Skowno | Sydney Children's Hospitals Network | Principal Investigator |
| Andrew J Davidson | Royal Children's Hospital | Principal Investigator |
| Britta Regli-von Ungern-Sternberg | Princess Margaret Hospital for Children, Perth, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| The Children's Hospital of Philadelphia |
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.
Limited dataset will be available to other researchers for up to 2 years after end of study.
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| OTHER |
| Yuying Children's Hospital of Wenzhou Medical University | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| Beijing Children's Hospital | OTHER |
| Shanghai Children's Medical Center | OTHER |
| Shengjing Hospital | OTHER |
| West China Hospital | OTHER |
| University of Geneva, Switzerland | OTHER |
| Erasmus Medical Center | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
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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 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Royal Children's Hospital (RCH, Melbourne, Australia) | Parkville | Victoria | 3052 | Australia |
| Princess Margaret Hospital for Children (PMH, Perth, Australia) | Subiaco | Western Australia | 6008 | Australia |
| Beijing Children's Hospital/Capital Medical University | Beijing | Beijing Municipality | 100045 | China |
| Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | 510620 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110003 | China |
| Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center | Shanghai | Shanghai Municipality | 200000 | China |
| West China Hospital, Sichuan University, China | Chengdu | Sichuan | 610041 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610071 | China |
| The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325027 | China |
| Erasmus MC Sophia Children's Hospital | Rotterdam | 3015 | Netherlands |
| University of Geneva | Geneva | Switzerland |