NCT06195345

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 1 Minute – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIE
• TBI (Traumatic Brain Injury)
• TBI
• Hemodynamic Instability
• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MR Imaging	MR imaging pertaining to the patient and project (ICHOR 1)

Timeline

• Start date: 2018-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-01-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study