Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04174001

Conditions

Cerebral Hemodynamics

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief 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). 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.

Conditions

Cerebral Hemodynamics

Study ID

NCT04174001

Start date

Feb 11, 2020

Status verified date

Feb, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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.

Exclusion criteria:

  • surgical procedure contraindicates the placement of NIRS probe on the forehead
  • scheduled for a cardiac procedure.
  • symptoms of neurological disorders (CONTROL GROUP ONLY)

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Changes in Cerebral Hemodynamics from baseline [ Time Frame: Through study completion; on average one year ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2024-02-23.