Multi-center Isoelectric EEG Study in Children Under General Anesthesia

NCT03432351 | Completed

• 1 other identifier: 17-014608
• Study Type: observational
• Target: 687
• Locations: 5 countries
• Sites: 15

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.

Conditions

Electroencephalography; General Anesthesia; Pediatric Anesthesia

Keywords

EEG; Electroencephalography; Pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Discontinuity of isoelectric EEG events among age groups

  Up to 12 months after EEG recording.

• Association of isoelectric EEG events between gender groups

  Up to 12 months after EEG recording

• Patient Weight associated with isoelectric EEG events

  Up to 12 months after EEG recording

• Changes in patient's physical status associated with isoelectric EEG events

  Up to 12 months after EEG recording

• Patient Gestational Age associated with isoelectric EEG events

  Up to 12 months after EEG recording

Study Arms (1)

Children: 0-36mo

EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention.

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

0-36 month old children undergoing general anesthesia for surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (15)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital (RCH, Melbourne, Australia)

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children (PMH, Perth, Australia)

Subiaco, Western Australia, 6008, Australia

Location

Beijing Children's Hospital/Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510620, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110003, China

Location

Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital, Sichuan University, China

Chengdu, Sichuan, 610041, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610071, China

Location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Erasmus MC Sophia Children's Hospital

Rotterdam, 3015, Netherlands

Location

University of Geneva

Geneva, Switzerland

Location

Study Officials

• Paula Hu

  Clinical Research Manager

  STUDY DIRECTOR

• Justin Skowno

  Sydney Children's Hospitals Network

  PRINCIPAL INVESTIGATOR

• Andrew J Davidson

  Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

• Britta Regli-von Ungern-Sternberg

  Princess Margaret Hospital for Children, Perth, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 14, 2018
• Study Start: June 21, 2018
• Primary Completion: December 13, 2019
• Study Completion: February 27, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Limited dataset will be available to other researchers for up to 2 years after end of study.

Locations

US (3); CN (7); NL (1); AU (3); CH (1)