ElectroencephalographyNCT03432351
Multi-center Isoelectric EEG Study in Children Under General Anesthesia
An observational study of Electroencephalography and General Anesthesia, run by Children's Hospital of Philadelphia at 15 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Electroencephalography, General Anesthesia, Pediatric Anesthesia
- How many people
- 687 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 21 Jun 2018to 27 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 0-36 month old children undergoing general anesthesia for surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
China7 sites
Beijing Children's Hospital/Capital Medical University
Beijing, Beijing Municipality, 100045
West China Hospital, Sichuan University, China
Chengdu, Sichuan, 610041
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610071
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510620
Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110003
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
United States3 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Medical Center Dallas
Dallas, Texas, 75235
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Australia3 sites
Royal Children's Hospital (RCH, Melbourne, Australia)
Parkville, Victoria, 3052
Princess Margaret Hospital for Children (PMH, Perth, Australia)
Subiaco, Western Australia, 6008
Children's Hospital at Westmead
Westmead, New South Wales, 2145
About this study
Official title: An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery
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.
Read the 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.
- Keywords
- EEG, Electroencephalography, Pediatric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children: 0-36mo | EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months after EEG recording
Secondary outcomes (13)
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
Measured: Up to 12 months after EEG recording.
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
Measured: Up to 12 months after EEG recording
Patient Weight associated with isoelectric EEG events
Weight (kg)
Measured: Up to 12 months after EEG recording
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.
Measured: Up to 12 months after EEG recording
Patient Gestational Age associated with isoelectric EEG events
Gestational Age (weeks)
Measured: Up to 12 months after EEG recording
Procedure length associated with isoelectric EEG events
Procedure length (min)
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 12 months after EEG recording.
Anesthesia Recovery time associated with isoelectric EEG events.
Recovery time (min)
Measured: Up to 12 months after EEG recording.
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.
Measured: Up to 2 months after EEG recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start21 Jun 2018
- Primary completion13 Dec 2019
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Sydney Children's Hospitals Network, Royal Children's Hospital, Princess Margaret Hospital for Children, Guangzhou Women and Children's Medical Center, Yuying Children's Hospital of Wenzhou Medical University, Sichuan Provincial People's Hospital, Beijing Children's Hospital, Shanghai Children's Medical Center, Shengjing Hospital, West China Hospital, University of Geneva, Switzerland, Erasmus Medical Center, Children's Hospital Medical Center, Cincinnati, University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Paula Hu, Study director, Clinical Research ManagerJustin Skowno, Principal investigator, Sydney Children's Hospitals NetworkAndrew J Davidson, Principal investigator, Royal Children's HospitalBritta Regli-von Ungern-Sternberg, Principal investigator, Princess Margaret Hospital for Children, Perth, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432351
- Sponsor's protocol ID
- 17-014608
- Status last verified
- Feb 2020
- First submitted
- 2 Jan 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery
- ClinicalTrials.gov ID
- NCT03432351
- Acronym / sponsor ID
- 17-014608
- Keywords
- EEG, Electroencephalography, Pediatric anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Sydney Children's Hospitals Network, Royal Children's Hospital, Princess Margaret Hospital for Children, Guangzhou Women and Children's Medical Center, Yuying Children's Hospital of Wenzhou Medical University, Sichuan Provincial People's Hospital, Beijing Children's Hospital, Shanghai Children's Medical Center, Shengjing Hospital, West China Hospital, University of Geneva, Switzerland, Erasmus Medical Center, Children's Hospital Medical Center, Cincinnati, University of Texas Southwestern Medical Center
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children: 0-36mo | – | –EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 0-36 month old children undergoing general anesthesia for surgery.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of isoelectric EEG events in young children.
Time frame: Up to 6 months after EEG recording
Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels.
13 secondary outcomes
Discontinuity of isoelectric EEG events among age groups
Time frame: Up to 12 months after EEG recording.
Association of isoelectric EEG events between gender groups
Time frame: Up to 12 months after EEG recording
Patient Weight associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording
Changes in patient's physical status associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording
Patient Gestational Age associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording
Procedure length associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording.
Incidence of anesthetic type
Time frame: Up to 12 months after EEG recording.
Anesthesia dose
Time frame: Up to 12 months after EEG recording.
Heart rate associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording.
Blood pressure associated with isoelectric EEG events
Time frame: Up to 12 months after EEG recording.
End tidal carbon dioxide (CO2) associated with isoelectric EEG events.
Time frame: Up to 12 months after EEG recording.
Anesthesia Recovery time associated with isoelectric EEG events.
Time frame: Up to 12 months after EEG recording.
Changes in quality of life
Time frame: Up to 2 months after EEG recording
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Hu study director
Clinical Research Manager
Justin Skowno principal investigator
Sydney Children's Hospitals Network
Andrew J Davidson principal investigator
Royal Children's Hospital
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalography and General Anesthesia, run by Children's Hospital of Philadelphia at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China, United States, Australia, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of isoelectric EEG events in young children. (time frame: Up to 6 months after EEG recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.