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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Limited dataset will be available to other researchers for up to 2 years after end of study.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03432351