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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03432351




Registration number
NCT03432351
Ethics application status
Date submitted
2/01/2018
Date registered
14/02/2018
Date last updated
28/02/2020

Titles & IDs
Public title
Multi-center Isoelectric EEG Study in Children Under General Anesthesia
Scientific title
An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery
Secondary ID [1] 0 0
17-014608
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Electroencephalography 0 0
General Anesthesia 0 0
Pediatric Anesthesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children: 0-36mo - EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of isoelectric EEG events in young children.
Timepoint [1] 0 0
Up to 6 months after EEG recording
Secondary outcome [1] 0 0
Discontinuity of isoelectric EEG events among age groups
Timepoint [1] 0 0
Up to 12 months after EEG recording.
Secondary outcome [2] 0 0
Association of isoelectric EEG events between gender groups
Timepoint [2] 0 0
Up to 12 months after EEG recording
Secondary outcome [3] 0 0
Patient Weight associated with isoelectric EEG events
Timepoint [3] 0 0
Up to 12 months after EEG recording
Secondary outcome [4] 0 0
Changes in patient's physical status associated with isoelectric EEG events
Timepoint [4] 0 0
Up to 12 months after EEG recording
Secondary outcome [5] 0 0
Patient Gestational Age associated with isoelectric EEG events
Timepoint [5] 0 0
Up to 12 months after EEG recording
Secondary outcome [6] 0 0
Procedure length associated with isoelectric EEG events
Timepoint [6] 0 0
Up to 12 months after EEG recording.
Secondary outcome [7] 0 0
Incidence of anesthetic type
Timepoint [7] 0 0
Up to 12 months after EEG recording.
Secondary outcome [8] 0 0
Anesthesia dose
Timepoint [8] 0 0
Up to 12 months after EEG recording.
Secondary outcome [9] 0 0
Heart rate associated with isoelectric EEG events
Timepoint [9] 0 0
Up to 12 months after EEG recording.
Secondary outcome [10] 0 0
Blood pressure associated with isoelectric EEG events
Timepoint [10] 0 0
Up to 12 months after EEG recording.
Secondary outcome [11] 0 0
End tidal carbon dioxide (CO2) associated with isoelectric EEG events.
Timepoint [11] 0 0
Up to 12 months after EEG recording.
Secondary outcome [12] 0 0
Anesthesia Recovery time associated with isoelectric EEG events.
Timepoint [12] 0 0
Up to 12 months after EEG recording.
Secondary outcome [13] 0 0
Changes in quality of life
Timepoint [13] 0 0
Up to 2 months after EEG recording

Eligibility
Key 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
Minimum age
No limit
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2020
Sample size
Target
Accrual to date
Final
687
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Children's Hospital (RCH, Melbourne, Australia) - Parkville
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children (PMH, Perth, Australia) - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Liaoning
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
China
State/province [8] 0 0
Sichuan
Country [9] 0 0
China
State/province [9] 0 0
Zhejiang
Country [10] 0 0
Netherlands
State/province [10] 0 0
Rotterdam
Country [11] 0 0
Switzerland
State/province [11] 0 0
Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Hospital of Philadelphia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sydney Children's Hospitals Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Princess Margaret Hospital for Children
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Guangzhou Women and Children's Medical Center
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Yuying Children's Hospital of Wenzhou Medical University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Sichuan Provincial People's Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Beijing Children's Hospital
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Shanghai Children's Medical Center
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Shengjing Hospital
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
West China Hospital
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University of Geneva, Switzerland
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Erasmus Medical Center
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Children's Hospital Medical Center, Cincinnati
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
University of Texas Southwestern Medical Center
Address [14] 0 0
Country [14] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03432351
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paula Hu
Address 0 0
Clinical Research Manager
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03432351