Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Overview
- Phase
- Not Applicable
- Intervention
- MR Imaging
- Conditions
- HIE
- Sponsor
- Children's Hospital Los Angeles
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Change in cerebral blood flow (ml blood/100g/min)
- Status
- Recruiting
- Last Updated
- 3 days ago
Overview
Brief Summary
This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.
Detailed Description
This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study. Treatment: Those who meet eligibility criteria, and who undergo the informed consent, will have their MRI extended by up to 7.5 minutes for up to 5 times. Standard-of-care anesthesia safety, dose and monitoring will not be changed. During their MRI, the additional images acquired will teach us about cerebral blood flow and cerebral venous oxygenation. Participants will also have non-invasive monitoring of their hematocrit immediately following the exam. Safety Assessment: The experiment will occur in the standard-of-care clinical MRI environment. All patient safety and monitoring will remain in place. Throughout the induction, maintenance and recovery from anesthesia, all procedures will occur in the standard of care environment and will be overseen by trained clinical personnel. Efficacy Assessment: Structural, and/or cerebral blood flow and/or metabolism MRIs will be collected from all subjects.
Investigators
Matthew Borzage
Principal Investigator
Children's Hospital Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Individuals who are able to tolerate an MRI.
- •Are patients scheduled for a clinically indicated MRI.
- •Between birth and up to 18 years.
Exclusion Criteria
- •Presence of an MRI-incompatible device or implant (e.g. pacemakers, stents)
- •Unable to tolerate the enclosed spaces and loud noises for the duration of time in scanner required to obtain an MRI.
- •Preterm infants less than 25 weeks
- •Any patient who is clinically too unstable to extend their MRI by up-to 7.5 minutes.
Arms & Interventions
Pediatric Patients
Children scheduled for clinical MR imaging.
Intervention: MR Imaging
Outcomes
Primary Outcomes
Change in cerebral blood flow (ml blood/100g/min)
Time Frame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.
Change in cerebral metabolic rate of oxygen (ml O2/100g/min)
Time Frame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.