Coronary SyndromeNCT04206683
Cerebral Oxygenation and Burst Suppression
An observational study of Coronary Syndrome and Pediatric, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Coronary Syndrome, Pediatric
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jan 2020to 30 Jun 2024
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- children between 6-36months
Who cannot join
- brain diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Children who are routinely operated for surgery that cause high levels of circulatory changes (e.g., heart surgery) are currently routinely used to monitor the so-called regional oxygenation technique over the brain, (NIRS). Near infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation, indirectly autoregulation in the brain. NIRS use has clinically resulted in an increased possibility of detecting episodes of regional ischemia that had not previously been recognized. Investigators do not know for sure what these episodes of impaired oxygenation in the brain can mean if not detect them in time and thus can correct them. There is no such research that has studied it in children. Investigators know that impaired oxygenation in the brain can occur with severe immediate blood loss. Investigators in the research group have been able to observe that in children who are otherwise healthy and who are operated for cranioplasty procedures <1 year old, when they have ongoing heavy bleeding, the oxygenation in the brain and sometimes sharply decreases before investigators can replace the blood loss, even though the blood pressure can be maintained adequately . Peroperative hypovolaemia is a factor that risks disrupting autoregulation in the brain. Regarding which median arterial pressure (MAP) is required to maintain intact autoregulation under general anesthesia, a scientific consensus is still lacking. Dagal \& Lam have shown that an MAP between 50-150 mmhg in adults indicates intact autoregulation, even though they claim that there is great individual variation. Research relating to children and autoregulation is limited, however, there is research on middle arterial pressure (MAP). Today at Drottning silvia's children and youth hospital -thorax surgeon, the Sahlgrenska University Hospital uses a monitor whose brand is called INVOS and which uses NIRS technology.
NIRS e.g. works practically by attaching a sensor to the skin in the area where monitoring is to be performed. By illuminating skin and underlying tissue with infrared light in spectra 700 to 1100 nm, it is possible to measure regional oxygen saturation in different tissues. In cerebral measurement, the sensor is placed frontally, just down the hairline. NIRS then returns absolute values (0-100%) of cerebral oxygen saturation frontally in the area where the sensor is located.
Today, NIRS is routinely used during open-hearth surgery. NIRS may indicate when ischemia or ongoing impaired autoregulation occurs. However, the weakness of the technique may be that even when a circulating organ does not extract oxygen, the NIRS value is high, which means that investigators cannot be completely sure of the values when they are high if other parts that affect the value (pH, mean arterial pressure etc.) are affected negatively. This means that supplementation with EEG e.g. BIS or Masimo technology could increase the possibility that even when "false for high values of NIRS" are detected and thus treatable. Regarding EEG and use on children, studies on deep anesthesia and burst suppression, where in their method similar technical equipment of BIS was used, which intenser in this study to detect burst suppression. Otherwise, the BIS or Masimo technique is used clinically during child anesthesia to part also, for example, at so-called. procedure investigations when one wants rapid flow rates of the study for a certain time, but also in the monitoring of children who have ongoing epileptic seizures when the technique has shown that it detects burst suppression. This new area of studying BS and utilizing and possibly this technology during open heart surgery, if possible, could increase safety even more for these many times already vulnerable children. Investigators want to observe a group of pediatric patients who will undergo open thoracic surgery with the support of a heart lung machine at Drottning Silvia's child and youth hospital, Sahlgrenska University Hospital. The purpose of the study is to study how the regional oxygenation one of the brain possibly has an influence on the emergence of so-called burst suppression. 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. Investigators intend to study 15 children according to statistical calculation see below. The time for data collection of the study is estimated at approx. 12 months.
- Conditions
- Coronary Syndrome, Pediatric
- Keywords
- brain saturation, burst suppression, general anesthesia, pediatric
- Medical subject headings
- Angina, Unstable
What is being measured
The primary outcome is the main question the study is designed to answer.
burst suppression (BS). Time of BS-percent during 1 minute, using Bispectral index monitor
percent 0-100 higher value worse
Measured: 1 minute
regional cerebral saturation, NIRS method will be used
percent 0-100 high value good
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start20 Jan 2020
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206683
- Sponsor's protocol ID
- 1066-18 20181230
- Status last verified
- Apr 2025
- First submitted
- 17 Dec 2019
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04206683
- Acronym / sponsor ID
- 1066-18 20181230
- Conditions
- Coronary Syndrome, Pediatric
- Keywords
- brain saturation, burst suppression, general anesthesia, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Dec 2019 (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.
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.
Detailed description
Children who are routinely operated for surgery that cause high levels of circulatory changes (e.g., heart surgery) are currently routinely used to monitor the so-called regional oxygenation technique over the brain, (NIRS). Near infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation, indirectly autoregulation in the brain. NIRS use has clinically resulted in an increased possibility of detecting episodes of regional ischemia that had not previously been recognized. Investigators do not know for sure what these episodes of impaired oxygenation in the brain can mean if not detect them in time and thus can correct them. There is no such research that has studied it in children. Investigators know that impaired oxygenation in the brain can occur with severe immediate blood loss. Investigators in the research group have been able to observe that in children who are otherwise healthy and who are operated for cranioplasty procedures <1 year old, when they have ongoing heavy bleeding, the oxygenation in the brain and sometimes sharply decreases before investigators can replace the blood loss, even though the blood pressure can be maintained adequately . Peroperative hypovolaemia is a factor that risks disrupting autoregulation in the brain. Regarding which median arterial pressure (MAP) is required to maintain intact autoregulation under general anesthesia, a scientific consensus is still lacking. Dagal \& Lam have shown that an MAP between 50-150 mmhg in adults indicates intact autoregulation, even though they claim that there is great individual variation. Research relating to children and autoregulation is limited, however, there is research on middle arterial pressure (MAP). Today at Drottning silvia's children and youth hospital -thorax surgeon, the Sahlgrenska University Hospital uses a monitor whose brand is called INVOS and which uses NIRS technology.
NIRS e.g. works practically by attaching a sensor to the skin in the area where monitoring is to be performed. By illuminating skin and underlying tissue with infrared light in spectra 700 to 1100 nm, it is possible to measure regional oxygen saturation in different tissues. In cerebral measurement, the sensor is placed frontally, just down the hairline. NIRS then returns absolute values (0-100%) of cerebral oxygen saturation frontally in the area where the sensor is located.
Today, NIRS is routinely used during open-hearth surgery. NIRS may indicate when ischemia or ongoing impaired autoregulation occurs. However, the weakness of the technique may be that even when a circulating organ does not extract oxygen, the NIRS value is high, which means that investigators cannot be completely sure of the values when they are high if other parts that affect the value (pH, mean arterial pressure etc.) are affected negatively. This means that supplementation with EEG e.g. BIS or Masimo technology could increase the possibility that even when "false for high values of NIRS" are detected and thus treatable. Regarding EEG and use on children, studies on deep anesthesia and burst suppression, where in their method similar technical equipment of BIS was used, which intenser in this study to detect burst suppression. Otherwise, the BIS or Masimo technique is used clinically during child anesthesia to part also, for example, at so-called. procedure investigations when one wants rapid flow rates of the study for a certain time, but also in the monitoring of children who have ongoing epileptic seizures when the technique has shown that it detects burst suppression. This new area of studying BS and utilizing and possibly this technology during open heart surgery, if possible, could increase safety even more for these many times already vulnerable children. Investigators want to observe a group of pediatric patients who will undergo open thoracic surgery with the support of a heart lung machine at Drottning Silvia's child and youth hospital, Sahlgrenska University Hospital. The purpose of the study is to study how the regional oxygenation one of the brain possibly has an influence on the emergence of so-called burst suppression. 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. Investigators intend to study 15 children according to statistical calculation see below. The time for data collection of the study is estimated at approx. 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- children between 6-36months
Key exclusion criteria (1 listed)
- brain diseases
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
burst suppression (BS). Time of BS-percent during 1 minute, using Bispectral index monitor
Time frame: 1 minute
percent 0-100 higher value worse
regional cerebral saturation, NIRS method will be used
Time frame: 1 minute
percent 0-100 high value good
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Syndrome and Pediatric, run by Göteborg University at 1 site in Sweden.
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 1 inclusion and 1 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
burst suppression (BS). Time of BS-percent during 1 minute, using Bispectral index monitor (time frame: 1 minute). The study lists 2 primary outcomes in all. 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 9 Sep 2025.