Monitoring brain blood flow in children during surgery
Bedside Cerebrovascular Autoregulation Monitoring in Children Under General Anesthesia
This study is testing a new way to monitor blood flow in the brains of children during surgery to help keep them safe and prevent complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04174001 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the importance of monitoring cerebral perfusion in pediatric patients undergoing neurosurgery under general anesthesia. It utilizes a novel technology called diffuse correlation spectroscopy (DCS) to non-invasively measure cerebral blood flow, aiming to ensure adequate cerebral perfusion and prevent neurological complications. The study addresses the challenges of maintaining safe blood pressure levels during anesthesia, particularly in children with neurological disorders. By continuously monitoring cerebral perfusion and oxygenation, the study seeks to improve outcomes for vulnerable pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 18 years or younger with neurological disorders who are scheduled for surgical procedures requiring general anesthesia.
Not a fit: Patients scheduled for cardiac procedures or those whose surgical procedure contraindicates the placement of monitoring devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for children undergoing neurosurgery by ensuring adequate cerebral perfusion.
How similar studies have performed: While the approach of using diffuse correlation spectroscopy is novel, other studies have shown the importance of monitoring cerebral hemodynamics in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Craig McClain — Boston Children's Hospital
- Study coordinator: Craig McClain, MD
- Email: Craig.McClain@childrens.harvard.edu
- Phone: 617-355-7737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.