Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1) (ICHOR 1)

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.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury); Hypoxic-Ischemic Encephalopathy; Hemodynamic Instability; TBI; HIE
• Intervention / Treatment: Diagnostic test: MR Imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hannah E Wiseman, MPH; Phone Number: 323-361-3963; Email: hwiseman@chla.usc.edu
• Study Contact Backup: Name: Matthew T Borzage, PhD; Phone Number: 323-601-5757; Email: mborzage@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Gabriel Luna; Phone Number: 323-361-8791; Email: hspp@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Neonates and young children

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric Patients; Children scheduled for clinical MR imaging.	Diagnostic test: MR Imaging; MR imaging pertaining to the patient and project (ICHOR 1); Other Names: MRI; Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cerebral blood flow (ml blood/100g/min)	Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.	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)	T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.	Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Matthew Borzage, PhD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2035

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Brain Ischemia; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Hypoxia-Ischemia, Brain; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Magnetic Resonance Imaging; Diagnostic Imaging
• Other Study ID Numbers: CHLA-18-00439; 5K25HL153954-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No