Recruiting NCT06195345

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

— Observational HIE TBI (Traumatic Brain Injury) TBI Hemodynamic Instability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: MR Imaging.
Who it may be relevant to: Registry conditions: HIE, TBI (Traumatic Brain Injury), TBI, Hemodynamic Instability. Basic parameters: 1 Minute — 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

Diagnostic test MR Imaging
MR imaging pertaining to the patient and project (ICHOR 1)

Primary outcome measures

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.]
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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Cohort

Study locations

United States · 1 center

Children's Hospital Los Angeles — Los Angeles

Identifiers

NCT: NCT06195345 · CHLA-18-00439 · 5K25HL153954-03

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗