Multi-center Isoelectric EEG Study in Children Under General Anesthesia

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432351
• Other study ID #: 17-014608
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: February 27, 2020

Study information

• Verified date: February 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 687
• Est. completion date: February 27, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Electroencephalography
• General Anesthesia
• Pediatric Anesthesia

Locations

Country	Name	City	State
Australia	Royal Children's Hospital (RCH, Melbourne, Australia)	Parkville	Victoria
Australia	Princess Margaret Hospital for Children (PMH, Perth, Australia)	Subiaco	Western Australia
Australia	Children's Hospital at Westmead	Westmead	New South Wales
China	Beijing Children's Hospital/Capital Medical University	Beijing	Beijing
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University, China	Chengdu	Sichuan
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
Netherlands	Erasmus MC Sophia Children's Hospital	Rotterdam
Switzerland	University of Geneva	Geneva
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (15)

Lead Sponsor

Collaborator

Children's Hospital of Philadelphia

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

Countries where clinical trial is conducted

United States,  Australia,  China,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Patient Weight associated with isoelectric EEG events	Weight (kg)	Up to 12 months after EEG recording
Secondary	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
Secondary	Patient Gestational Age associated with isoelectric EEG events	Gestational Age (weeks)	Up to 12 months after EEG recording
Secondary	Procedure length associated with isoelectric EEG events	Procedure length (min)	Up to 12 months after EEG recording.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Anesthesia Recovery time associated with isoelectric EEG events.	Recovery time (min)	Up to 12 months after EEG recording.
Secondary	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