Blood FlowBAMBINCT06886698
MRI Assesment of Cerebral Blood Flow in Anesthetized Children
An observational study of Blood Flow and Cerebral Oxygenation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Children undergoing magnetic resonance imaging (MRI) of the brain often need to be sedated to complete the examination, as it is difficult to remain still for a long period, which is required to obtain usable images. During sedation, most patients typically experience a drop in blood pressure, including children. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Blood Flow, Cerebral Oxygenation, Blood Pressure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years
Who may be able to join
- children aged 6 months to 12 years
- Planned to undergo MRI brain
Who cannot join
- known brain tumor
- vascular malformation in the brain
- hydrocephalus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska University Hospital
Solna, 171 64
Peter Larsson, MD PhD, +46812370000, peter.larsson@regionstockholm.se
Titus Schlinzig, MD PhD, +46812370000, titus.schlinzig@regionstockholm.se
About this study
Official title: Arterial Spin Label Assessment of Cerebral Blood Flow in Anesthetized Children
Children undergoing magnetic resonance imaging (MRI) of the brain often need to be sedated to complete the examination, as it is difficult to remain still for a long period, which is required to obtain usable images. During sedation, most patients typically experience a drop in blood pressure, including children. Maintaining an adequate blood pressure under anesthesia is important, as blood pressure is routinely used as a measure to ensure sufficient blood circulation to the body's organs, including the brain. Ensuring adequate blood flow to the brain is one of the cornerstones of all anesthesia, including in children. Therefore, low blood pressure during anesthesia is often treated with standardized interventions, such as blood pressure-raising interventions. These treatments generally restore blood pressure to normal, but how this affects blood flow to the brain in children is not fully known.
With the help of modern MRI technology (so-called Arterial Spin Labeling, ASL), blood flow in the brain can be measured quickly and completely safely with high precision.
Read more
In similar situations with adult patients, it has been observed that while blood pressure-raising interventions successfully normalize low blood pressure, MRI scans show that blood flow to the brain paradoxically decreases despite the increase in blood pressure. It is believed that this may be due to the brain's blood vessels constricting.
The investigators now wish to examine this relationship in sedated children undergoing planned brain MRI for certain diagnoses. The investigators hypothesis is that standardized measures intended to raise blood pressure (i.e., the routine treatment used regardless of whether a patient participates in the study or not) normalizes low blood pressure (when deemed necessary to treat according to routine) but does not necessarily lead to improved blood flow to the brain.
Primary research question: How does routine treatment of low blood pressure affect cerebral blood flow in sedated children?
Read the detailed description
Patients undergoing sedation for brain MRI will be identified based on the surgical schedule . If no exclusion criteria are met, the child will be eligible for inclusion in the study, and both the child and their guardians will be informed, with consent requested and obtained.
Basic data regarding the patient's health status, age, sex, and weight will be collected and stored on a dedicated research computer.
The anesthesia procedure for MRI examinations routinely involves measuring blood pressure before administering premedication. A peripheral venous catheter (PVC) is then placed, after which the child is sedated with a propofol infusion (an anesthetic drug). Oxygen is routinely provided via nasal cannula. Standard monitoring includes heart rate, blood pressure, and blood oxygen saturation. All study participants will be prepared, sedated, and monitored according to this standard procedure, exactly as would be done regardless of whether they participate in the study or not.
Once the child is placed in the MRI scanner, the examination proceeds as per routine. Blood pressure is measured every five minutes. As soon as the mean arterial pressure (MAP) drops by more than 20% from baseline (i.e., the blood pressure measured when the patient was awake), brain blood flow measurement using an ASL sequence in the MRI machine will begin. ASL, or Arterial Spin Labeling, is a safe MRI technique for measuring cerebral blood flow without the need for contrast injection. This method magnetically "labels" the blood and then tracks its movement into the brain, providing valuable information about cerebral perfusion. ASL is already routinely used in children undergoing MRI for conditions such as epilepsy, brain tumors, and headaches.
The ASL sequence will be initiated immediately upon detecting the blood pressure drop. Subsequently, blood pressure will be managed according to clinical routine (this management will be performed regardless of study participation), and brain blood flow will be recorded during the ASL sequence. Clinical routine management primarily involves administering intravenous blood pressure-raising medications. The ASL sequence itself takes approximately 12 minutes. Once the study protocol is completed, the MRI examination and anesthesia/monitoring will continue as per routine until completion.
Data collected from the ASL scans will then be processed using specialized software for further analysis. ASL recording will begin upon detecting a >20% drop in blood pressure, after which blood pressure will be treated according to routine. Normally, no pre-prepared blood pressure treatment is available, meaning it must be prepared at the time (e.g., blood pressure-raising medication). This preparation is estimated to take approximately 3 minutes, so the additional 12-minute sequence effectively extends the MRI duration by about (12-3) = 9 minutes (practically, this is expected to add around 10-15 extra minutes). In context, this additional time is negligible for the patient, as time windows of 10-15 minutes are common during MRI, for example, when waiting for image interpretation or adding new sequences (such as ASL, which is sometimes included for additional information, regardless of study participation).
The study will not result in an increased number of visits for research participants
- Conditions
- Blood Flow, Cerebral Oxygenation, Blood Pressure
- Keywords
- anesthesia, bloodflow, brain, children
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 |
|---|---|---|
| pediatric MRI | Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cerebral blood flow in response to hypotension treatment
Quantification of cerebral blood flow using Arterial Spin Labeling during hypotension and subsequently in response to standardized treatment of hypotension as per departmental standard operating procedure.
Measured: From detection of hypotension to assessment of immediate change in cebrebral bloodflow, data reported after approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood FlowStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Jacob Karlsson, Karolinska Institutet
- Investigators
- Jacob Karlsson, MD PhD Associate Professor, Principal investigator, Karolinska Universitets Sjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886698
- Sponsor's protocol ID
- K 2025-0337
- Other IDs
- Region Stockholm
- Acronym
- BAMBI
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Spin Label Assessment of Cerebral Blood Flow in Anesthetized Children
- ClinicalTrials.gov ID
- NCT06886698
- Acronym / sponsor ID
- BAMBI / K 2025-0337
- Conditions
- Blood Flow, Cerebral Oxygenation, Blood Pressure
- Keywords
- anesthesia, bloodflow, brain, children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 20 Mar 2025 (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.
Children undergoing magnetic resonance imaging (MRI) of the brain often need to be sedated to complete the examination, as it is difficult to remain still for a long period, which is required to obtain usable images. During sedation, most patients typically experience a drop in blood pressure, including children. Maintaining an adequate blood pressure under anesthesia is important, as blood pressure is routinely used as a measure to ensure sufficient blood circulation to the body's organs, including the brain. Ensuring adequate blood flow to the brain is one of the cornerstones of all anesthesia, including in children. Therefore, low blood pressure during anesthesia is often treated with standardized interventions, such as blood pressure-raising interventions. These treatments generally restore blood pressure to normal, but how this affects blood flow to the brain in children is not fully known.
With the help of modern MRI technology (so-called Arterial Spin Labeling, ASL), blood flow in the brain can be measured quickly and completely safely with high precision.
In similar situations with adult patients, it has been observed that while blood pressure-raising interventions successfully normalize low blood pressure, MRI scans show that blood flow to the brain paradoxically decreases despite the increase in blood pressure. It is believed that this may be due to the brain's blood vessels constricting.
The investigators now wish to examine this relationship in sedated children undergoing planned brain MRI for certain diagnoses. The investigators hypothesis is that standardized measures intended to raise blood pressure (i.e., the routine treatment used regardless of whether a patient participates in the study or not) normalizes low blood pressure (when deemed necessary to treat according to routine) but does not necessarily lead to improved blood flow to the brain.
Primary research question: How does routine treatment of low blood pressure affect cerebral blood flow in sedated children?
Detailed description
Patients undergoing sedation for brain MRI will be identified based on the surgical schedule . If no exclusion criteria are met, the child will be eligible for inclusion in the study, and both the child and their guardians will be informed, with consent requested and obtained.
Basic data regarding the patient's health status, age, sex, and weight will be collected and stored on a dedicated research computer.
The anesthesia procedure for MRI examinations routinely involves measuring blood pressure before administering premedication. A peripheral venous catheter (PVC) is then placed, after which the child is sedated with a propofol infusion (an anesthetic drug). Oxygen is routinely provided via nasal cannula. Standard monitoring includes heart rate, blood pressure, and blood oxygen saturation. All study participants will be prepared, sedated, and monitored according to this standard procedure, exactly as would be done regardless of whether they participate in the study or not.
Once the child is placed in the MRI scanner, the examination proceeds as per routine. Blood pressure is measured every five minutes. As soon as the mean arterial pressure (MAP) drops by more than 20% from baseline (i.e., the blood pressure measured when the patient was awake), brain blood flow measurement using an ASL sequence in the MRI machine will begin. ASL, or Arterial Spin Labeling, is a safe MRI technique for measuring cerebral blood flow without the need for contrast injection. This method magnetically "labels" the blood and then tracks its movement into the brain, providing valuable information about cerebral perfusion. ASL is already routinely used in children undergoing MRI for conditions such as epilepsy, brain tumors, and headaches.
The ASL sequence will be initiated immediately upon detecting the blood pressure drop. Subsequently, blood pressure will be managed according to clinical routine (this management will be performed regardless of study participation), and brain blood flow will be recorded during the ASL sequence. Clinical routine management primarily involves administering intravenous blood pressure-raising medications. The ASL sequence itself takes approximately 12 minutes. Once the study protocol is completed, the MRI examination and anesthesia/monitoring will continue as per routine until completion.
Data collected from the ASL scans will then be processed using specialized software for further analysis. ASL recording will begin upon detecting a >20% drop in blood pressure, after which blood pressure will be treated according to routine. Normally, no pre-prepared blood pressure treatment is available, meaning it must be prepared at the time (e.g., blood pressure-raising medication). This preparation is estimated to take approximately 3 minutes, so the additional 12-minute sequence effectively extends the MRI duration by about (12-3) = 9 minutes (practically, this is expected to add around 10-15 extra minutes). In context, this additional time is negligible for the patient, as time windows of 10-15 minutes are common during MRI, for example, when waiting for image interpretation or adding new sequences (such as ASL, which is sometimes included for additional information, regardless of study participation).
The study will not result in an increased number of visits for research participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric MRI | – | –Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients scheduled for brain MRI under anesthesia, aged 6 months to 12 years
Key inclusion criteria (2 listed)
- children aged 6 months to 12 years
- Planned to undergo MRI brain
Key exclusion criteria (3 listed)
- known brain tumor
- vascular malformation in the brain
- hydrocephalus
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
Changes in cerebral blood flow in response to hypotension treatment
Time frame: From detection of hypotension to assessment of immediate change in cebrebral bloodflow, data reported after approximately one year
Quantification of cerebral blood flow using Arterial Spin Labeling during hypotension and subsequently in response to standardized treatment of hypotension as per departmental standard operating procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jacob Karlsson, MD PhD Associate Professor principal investigator
Karolinska Universitets Sjukhuset
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 Blood Flow and Cerebral Oxygenation, run by Karolinska Institutet 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Karlsson, MD PhD Associate Professor (+46737145217, jacob.karlsson.1@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cerebral blood flow in response to hypotension treatment (time frame: From detection of hypotension to assessment of immediate change in cebrebral bloodflow, data reported after approximately one year). 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 25 Mar 2025.