Clinical trial NCT03432351: Multi-center Isoelectric EEG Study in Children Under General Anesthesia
Official title: An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electroencephalography
General Anesthesia
Pediatric Anesthesia
Keywords: EEG
Electroencephalography
Pediatric anesthesia
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Sydney Children's Hospitals Network
name: Royal Children's Hospital
name: Princess Margaret Hospital for Children
name: Guangzhou Women and Children's Medical Center
name: Yuying Children's Hospital of Wenzhou Medical University
name: Sichuan Provincial People's Hospital
name: Beijing Children's Hospital
name: Shanghai Children's Medical Center
name: Shengjing Hospital
name: West China Hospital
name: University of Geneva, Switzerland
name: Erasmus Medical Center
name: Children's Hospital Medical Center, Cincinnati
name: University of Texas Southwestern Medical Center
First posted: 2018-02-14
Enrollment: 687
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 0-36 month old children undergoing general anesthesia for surgery.

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.

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

Primary outcomes:
measure: Incidence of isoelectric EEG events in young children.
timeFrame: Up to 6 months after EEG recording
Secondary outcomes:
measure: Discontinuity of isoelectric EEG events among age groups
timeFrame: Up to 12 months after EEG recording.
measure: Association of isoelectric EEG events between gender groups
timeFrame: Up to 12 months after EEG recording
measure: Patient Weight associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording
measure: Changes in patient's physical status associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording
measure: Patient Gestational Age associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording
measure: Procedure length associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording.
measure: Incidence of anesthetic type
timeFrame: Up to 12 months after EEG recording.
measure: Anesthesia dose
timeFrame: Up to 12 months after EEG recording.
measure: Heart rate associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording.
measure: Blood pressure associated with isoelectric EEG events
timeFrame: Up to 12 months after EEG recording.
measure: End tidal carbon dioxide (CO2) associated with isoelectric EEG events.
timeFrame: Up to 12 months after EEG recording.
measure: Anesthesia Recovery time associated with isoelectric EEG events.
timeFrame: Up to 12 months after EEG recording.
measure: Changes in quality of life
timeFrame: Up to 2 months after EEG recording
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Westmead
country: Australia
facility: Children's Hospital at Westmead
state: New South Wales
city: Parkville
country: Australia
facility: Royal Children's Hospital (RCH, Melbourne, Australia)
state: Victoria
city: Subiaco
country: Australia
facility: Princess Margaret Hospital for Children (PMH, Perth, Australia)
state: Western Australia
city: Beijing
country: China
facility: Beijing Children's Hospital/Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University, China
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
city: Rotterdam
country: Netherlands
facility: Erasmus MC Sophia Children's Hospital
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: Clinical Research Manager
name: Paula Hu
role: STUDY_DIRECTOR
affiliation: Sydney Children's Hospitals Network
name: Justin Skowno
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Children's Hospital
name: Andrew J Davidson
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital for Children, Perth, Australia
name: Britta Regli-von Ungern-Sternberg
role: PRINCIPAL_INVESTIGATOR
References: