Cerebral Oxygenation and Burst Suppression
How Does Cerebral-measured Oxygenation and Burst Suppression Correlate Cranially Frontally in Children Between 6 and 36 Months Old, During General Anesthesia and Open Thoracic Surgery Supported by Cardiac Pulmonary Machine
1 other identifier
observational
15
1 country
1
Brief Summary
investigators want to observe a group of pediatric patients who are going to undergo open thoracic surgery at Queen Silvia's child and youth hospital, Sahlgrenska University Hospital. Population that has been selected is between 6-36 months due to the fact that the physiological development does not differ significantly with respect to drug response and circulation. During general anesthesia and surgery, investigators will use an NIRS). A sensor is placed frontally on the head. This comparative study will study the relationship between regional oxygenation frontal and 2/4-channel EEG. An EEG sensor with adhesive will also be attached to the frontal on patient's forehead next to tendons from NIRS. Participants will be consulted consecutively at the thoracic surgeon who will undergo open thoracic surgery with the support of the hair removal machine and who have the intended age for the study at Queen Silvia's Children's and Youth Hospital, Salhgrenska University Hospital. Peroperatively, data collection will occur in 5-minute intervals for frontal and occipital measurements. The measurements are started before the patient is anesthetized and terminated when the patient is awakened. Usual monitoring parameters under general anesthesia will be collected and documented, see protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 9, 2025
April 1, 2025
4.4 years
December 17, 2019
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
burst suppression (BS). Time of BS-percent during 1 minute, using Bispectral index monitor
percent 0-100 higher value worse
1 minute
regional cerebral saturation, NIRS method will be used
percent 0-100 high value good
1 minute
Eligibility Criteria
This comparative study will study the relationship between regional oxygenation frontal and 2/4-channel EEG). An EEG sensor with adhesive will also be attached to the frontal on patient's forehead next to tendons from NIRS.
You may qualify if:
- children between 6-36months
You may not qualify if:
- brain diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gothenburg, Children Hospital
Gothenburg, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2019
First Posted
December 20, 2019
Study Start
January 20, 2020
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
September 9, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share