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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03432351
Ethics application status
Date submitted
2/01/2018
Date registered
7/02/2018
Date last updated
4/01/2019

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. - Isoelectric EEG event is defined as low amplitude EEG for = 2 seconds simultaneously across all 4 EEG channels.
Timepoint [1] 0 0
Up to 6 months after EEG recording
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 12 months after EEG recording.
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 12 months after EEG recording
Secondary outcome [3] 0 0
Patient Weight associated with isoelectric EEG events - Weight (kg)
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 - 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.
Timepoint [4] 0 0
Up to 12 months after EEG recording
Secondary outcome [5] 0 0
Patient Gestational Age associated with isoelectric EEG events - Gestational Age (weeks)
Timepoint [5] 0 0
Up to 12 months after EEG recording
Secondary outcome [6] 0 0
Procedure length associated with isoelectric EEG events - Procedure length (min)
Timepoint [6] 0 0
Up to 12 months after EEG recording.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to 12 months after EEG recording.
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to 12 months after EEG recording.
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Up to 12 months after EEG recording.
Secondary outcome [10] 0 0
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.
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. - 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.
Timepoint [11] 0 0
Up to 12 months after EEG recording.
Secondary outcome [12] 0 0
Anesthesia Recovery time associated with isoelectric EEG events. - Recovery time (min)
Timepoint [12] 0 0
Up to 12 months after EEG recording.
Secondary outcome [13] 0 0
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.
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Ian Yuan, MD
Address 0 0
Country 0 0
Phone 0 0
3022990805
Fax 0 0
Email 0 0
yuani@email.chop.edu
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable