Cerebral HemodynamicsNCT04174001
Perioperative Cerebrovascular Autoregulation Monitoring in Neurosurgical Patients
An observational study of Cerebral Hemodynamics, run by Boston Children's Hospital at 1 site in United States.
Trial summary
One of the challenges in pediatric anesthesiology is to ensure adequate cerebral perfusion pressure to prevent cerebral ischemia or hyperemia from pressure-passive perfusion. However, there is no optimal tool for longitudinally monitoring cerebral perfusion under general anesthesia (GA). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cerebral Hemodynamics
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2020to Dec 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We plan to enroll 20 subjects for the Neuro group and 10 subjects for the Control group.
Who may be able to join
- 18 years of age or younger
- diagnosed as one or more of the neurological disorders, including but not limiting to moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke (NEURO GROUP ONLY)
- planned for any surgical procedures that required general anesthesia (CONTROL GROUP ONLY)
- planned for any surgical procedures that required general anesthesia
- planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring.
Who cannot join
- surgical procedure contraindicates the placement of NIRS probe on the forehead
- scheduled for a cardiac procedure.
- symptoms of neurological disorders (CONTROL GROUP ONLY)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Craig McClain, MD, 617-355-7737, craig.mcclain@childrens.harvard.edu
About this study
Official title: Bedside Cerebrovascular Autoregulation Monitoring in Children Under General Anesthesia
One of the challenges in pediatric anesthesiology is to ensure adequate cerebral perfusion pressure to prevent cerebral ischemia or hyperemia from pressure-passive perfusion. However, there is no optimal tool for longitudinally monitoring cerebral perfusion under general anesthesia (GA). In addition, the safe limits of blood pressure that maintains adequate cerebral perfusion in infants and children are not clear. Furthermore, patients with neurological impairments may have impaired cerebral auto-regulation (CA) function which may associated with functional outcomes. To address the critical public health issues associated with the safe use of general anesthesia in during neurosurgery, monitoring cerebral perfusion and oxygenation continuously during the peri-operative period.
The investigators have pioneered a novel technology, diffuse correlation spectroscopy (DCS), to optically measure cerebral blood flow (CBF) non-invasively and demonstrated that it is safe and practical as a bedside CBF monitor in the NICU. Blood flow is distinct from blood oxygenation, but both are important for brain health. Clinical near infrared spectroscopy (NIRS) devices are available to monitor oxygenation by light absorption, but CBF must be monitored by light scattering, which is only available with research DCS devices. While the physical principles of the methods are different, the sensors for both techniques are very similar. The investigators have therefore combined DCS with advanced frequency-domain NIRS (FDNIRS) in a single device to simultaneously monitor cerebral tissue oxygen saturation (cStO2), blood volume (CBV), CBF and oxygen metabolism (CMRO2), which cannot be monitored with existing clinical devices. The investigators have previously shown that these measures are far more sensitive than cStO2 alone in several infant brain pathologies. In this study, the investigators aim to test the feasibility of integrating the FDNIRS-DCS technology into perioperative monitoring to study cerebral hemodynamics and oxygen metabolism continuously in children during general anesthesia and surgery. Additionally, the investigators will determine how anesthesia-related events affect cerebral hemodynamic instability and how anesthetic level correlates with CA functions in children.
Read the detailed description
Cerebral autoregulation (CA) is a mechanism that maintains cerebral flood flow (CBF) despite the fluctuations in the arterial blood pressure. This process protects the brain from ischemic or hemorrhagic insults during events of hypo- or hyperperfusion, respectively. Children under general anesthesia (GA) are particularly vulnerable to these events because anesthetic agents profoundly impact cerebral metabolic supply and demand. At the same time, to varying degrees, anesthetic agents can compromise respiration, produce hypotension, and even inhibit cerebral autoregulation function. General anesthesia-induced cerebral hypoperfusion can occur during routine GA and is associated with deleterious neurological outcomes in children. Thus, primary goals in managing GA are therefore to maintain adequate hemodynamics and cerebral perfusion under intact CA.
A recent large retrospective study demonstrated that blood pressure ranges in anesthetized children are significantly lower than in awake, healthy children. However, the safe limits of blood pressure that maintains adequate cerebral perfusion in infants and children are not clear and my vary depending on the age and disease severity. Currently, bedside CBF monitoring had been impractical. Transcranial Doppler ultrasound (TCD) is the only clinically available tool to measure cerebral blood flow velocity in larger arteries. Although TCD has been used for obtaining cerebral hemodynamics including autoregulation for clinical use, it is not practical for long-term monitoring due to the difficulty to secure the probe on the patient's head. Furthermore, the accuracy of the TCD measurement is highly operator-dependent which impedes its general use.
Cerebral oximeters, based on near-infrared spectroscopy (NIRS) have become popular means of assessing cerebral hemoglobin oxygen saturation (cStO2) during GA, but its use has not become routine. Clinically relevant desaturation (generally below 50-60 percent) implies a mismatch between brain oxygen supply and demand. When presenting persistently, they can serve as an intraoperative warning sign of hemodynamic and metabolic comprise. A recent study with 453 healthy infants undergoing general anesthesia for non-cardiac surgery found the episodes of desaturation is rare (2%) despite that critically low blood pressure (MAP <35 mmHg) was observed in almost 40% of subjects. Because desaturation events are relatively rare, they are unlikely to be responsible for adverse outcomes in non-cardiac surgery. However, the magnitude of the change in cStO2 from the awake to anesthetized state was associated with the range of MAP experienced during GA, suggesting systematic changes in cerebral perfusion may be more important than desaturation events for assessing hemodynamic risk.
To address the critical public health issues associated with the safe use of anesthesia in children, the investigators propose to develop new beside tools to monitor cerebral hemodynamics and perfusion continuously during anesthesia. The investigators aim to quantify cStO2, CBF, CMRO2, and its coupling relationship in children with and without neurologic impairments while awake and during different phases of GA (aim1). With continuous measures of arterial blood pressure, the investigators will further determine CA functions by studying the relationship between CBF and ABP simultaneously with anesthesia-related physiological events, including hypercapnia (aim2). Ultimately, the investigators aim to integrate our technology into perioperative monitoring to enable age-appropriate, goal-directed cerebral hemodynamic management to spare infant brains from the potentially deleterious effects of anesthesia.
- Conditions
- Cerebral Hemodynamics
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 |
|---|---|---|
| Neuro group | Patients who meet the following criteria: * 18 years of age or younger * diagnosed with one or more of the following neurological disorders: moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke * planned for any surgical procedures that require general anesthesia * planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or are scheduled for a cardiac procedure will be excluded. | |
| Control group | Patients who meet the following criteria: * 18 years of age or younger-planned for any surgical procedures that require general anesthesia * planned postoperative invasive blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or have symptoms of neurological disorders will be excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cerebral Hemodynamics from baseline
Changes in frequency domain near infrared spectroscopy - diffuse correlation spectroscopy (FDNIRS-DCS) measurements from baseline to determine what factors are correlated with changes in the cerebral hemodynamics and auto regulation. This will be monitored at baseline pre-operatively, intraoperatively, post-operatively while in-patient, and at follow-up visits for up to one year.
Measured: Through study completion; on average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Feb 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemodynamicsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig McClain, Boston Children's Hospital
- Investigators
- Craig McClain, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174001
- Sponsor's protocol ID
- P00031784
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2019
- Last updated
- 23 Feb 2024
- Results posted
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Cerebrovascular Autoregulation Monitoring in Children Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04174001
- Acronym / sponsor ID
- P00031784
- Conditions
- Cerebral Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Nov 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.
One of the challenges in pediatric anesthesiology is to ensure adequate cerebral perfusion pressure to prevent cerebral ischemia or hyperemia from pressure-passive perfusion. However, there is no optimal tool for longitudinally monitoring cerebral perfusion under general anesthesia (GA). In addition, the safe limits of blood pressure that maintains adequate cerebral perfusion in infants and children are not clear. Furthermore, patients with neurological impairments may have impaired cerebral auto-regulation (CA) function which may associated with functional outcomes. To address the critical public health issues associated with the safe use of general anesthesia in during neurosurgery, monitoring cerebral perfusion and oxygenation continuously during the peri-operative period.
The investigators have pioneered a novel technology, diffuse correlation spectroscopy (DCS), to optically measure cerebral blood flow (CBF) non-invasively and demonstrated that it is safe and practical as a bedside CBF monitor in the NICU. Blood flow is distinct from blood oxygenation, but both are important for brain health. Clinical near infrared spectroscopy (NIRS) devices are available to monitor oxygenation by light absorption, but CBF must be monitored by light scattering, which is only available with research DCS devices. While the physical principles of the methods are different, the sensors for both techniques are very similar. The investigators have therefore combined DCS with advanced frequency-domain NIRS (FDNIRS) in a single device to simultaneously monitor cerebral tissue oxygen saturation (cStO2), blood volume (CBV), CBF and oxygen metabolism (CMRO2), which cannot be monitored with existing clinical devices. The investigators have previously shown that these measures are far more sensitive than cStO2 alone in several infant brain pathologies. In this study, the investigators aim to test the feasibility of integrating the FDNIRS-DCS technology into perioperative monitoring to study cerebral hemodynamics and oxygen metabolism continuously in children during general anesthesia and surgery. Additionally, the investigators will determine how anesthesia-related events affect cerebral hemodynamic instability and how anesthetic level correlates with CA functions in children.
Detailed description
Cerebral autoregulation (CA) is a mechanism that maintains cerebral flood flow (CBF) despite the fluctuations in the arterial blood pressure. This process protects the brain from ischemic or hemorrhagic insults during events of hypo- or hyperperfusion, respectively. Children under general anesthesia (GA) are particularly vulnerable to these events because anesthetic agents profoundly impact cerebral metabolic supply and demand. At the same time, to varying degrees, anesthetic agents can compromise respiration, produce hypotension, and even inhibit cerebral autoregulation function. General anesthesia-induced cerebral hypoperfusion can occur during routine GA and is associated with deleterious neurological outcomes in children. Thus, primary goals in managing GA are therefore to maintain adequate hemodynamics and cerebral perfusion under intact CA.
A recent large retrospective study demonstrated that blood pressure ranges in anesthetized children are significantly lower than in awake, healthy children. However, the safe limits of blood pressure that maintains adequate cerebral perfusion in infants and children are not clear and my vary depending on the age and disease severity. Currently, bedside CBF monitoring had been impractical. Transcranial Doppler ultrasound (TCD) is the only clinically available tool to measure cerebral blood flow velocity in larger arteries. Although TCD has been used for obtaining cerebral hemodynamics including autoregulation for clinical use, it is not practical for long-term monitoring due to the difficulty to secure the probe on the patient's head. Furthermore, the accuracy of the TCD measurement is highly operator-dependent which impedes its general use.
Cerebral oximeters, based on near-infrared spectroscopy (NIRS) have become popular means of assessing cerebral hemoglobin oxygen saturation (cStO2) during GA, but its use has not become routine. Clinically relevant desaturation (generally below 50-60 percent) implies a mismatch between brain oxygen supply and demand. When presenting persistently, they can serve as an intraoperative warning sign of hemodynamic and metabolic comprise. A recent study with 453 healthy infants undergoing general anesthesia for non-cardiac surgery found the episodes of desaturation is rare (2%) despite that critically low blood pressure (MAP <35 mmHg) was observed in almost 40% of subjects. Because desaturation events are relatively rare, they are unlikely to be responsible for adverse outcomes in non-cardiac surgery. However, the magnitude of the change in cStO2 from the awake to anesthetized state was associated with the range of MAP experienced during GA, suggesting systematic changes in cerebral perfusion may be more important than desaturation events for assessing hemodynamic risk.
To address the critical public health issues associated with the safe use of anesthesia in children, the investigators propose to develop new beside tools to monitor cerebral hemodynamics and perfusion continuously during anesthesia. The investigators aim to quantify cStO2, CBF, CMRO2, and its coupling relationship in children with and without neurologic impairments while awake and during different phases of GA (aim1). With continuous measures of arterial blood pressure, the investigators will further determine CA functions by studying the relationship between CBF and ABP simultaneously with anesthesia-related physiological events, including hypercapnia (aim2). Ultimately, the investigators aim to integrate our technology into perioperative monitoring to enable age-appropriate, goal-directed cerebral hemodynamic management to spare infant brains from the potentially deleterious effects of anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro group | – | –Patients who meet the following criteria: * 18 years of age or younger * diagnosed with one or more of the following neurological disorders: moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke * planned for any surgical procedures that require general anesthesia * planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or are scheduled for a cardiac procedure will be excluded. |
| Control group | – | –Patients who meet the following criteria: * 18 years of age or younger-planned for any surgical procedures that require general anesthesia * planned postoperative invasive blood pressure monitoring Patients who have a surgical procedure that contraindicates the placement of a NIRS probe on the forehead or have symptoms of neurological disorders will be excluded. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We plan to enroll 20 subjects for the Neuro group and 10 subjects for the Control group.
Key inclusion criteria (5 listed)
- 18 years of age or younger
- diagnosed as one or more of the neurological disorders, including but not limiting to moyamoya disease, congenital anomalies of the brain, hypoxic-ischemic encephalopathy, brain tumor, Chiari malformation, epilepsy and stroke (NEURO GROUP ONLY)
- planned for any surgical procedures that required general anesthesia (CONTROL GROUP ONLY)
- planned for any surgical procedures that required general anesthesia
- planned to receive intraoperative and/or postoperative invasive arterial blood pressure monitoring.
Key exclusion criteria (3 listed)
- surgical procedure contraindicates the placement of NIRS probe on the forehead
- scheduled for a cardiac procedure.
- symptoms of neurological disorders (CONTROL GROUP ONLY)
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 Hemodynamics from baseline
Time frame: Through study completion; on average one year
Changes in frequency domain near infrared spectroscopy - diffuse correlation spectroscopy (FDNIRS-DCS) measurements from baseline to determine what factors are correlated with changes in the cerebral hemodynamics and auto regulation. This will be monitored at baseline pre-operatively, intraoperatively, post-operatively while in-patient, and at follow-up visits for up to one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- 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.
Craig McClain principal investigator
Boston Children's Hospital
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 Cerebral Hemodynamics, run by Boston Children's Hospital at 1 site in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig McClain, MD (617-355-7737, Craig.McClain@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cerebral Hemodynamics from baseline (time frame: Through study completion; on average 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 23 Feb 2024.