Clinical trial NCT06195345: Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Official title: Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIE
TBI (Traumatic Brain Injury)
TBI
Hemodynamic Instability
Hypoxic-Ischemic Encephalopathy
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and young children

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.

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.

Primary outcomes:
measure: Change in cerebral blood flow (ml blood/100g/min)
timeFrame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
measure: Change in cerebral metabolic rate of oxygen (ml O2/100g/min)
timeFrame: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
References: