Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

Hemodynamic Instability Clinical Trial

— ICHOR 1  

Official title:

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195345
• Other study ID #: CHLA-18-00439
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: Children's Hospital Los Angeles
• Contact: Hannah E Wiseman, MPH
• Phone: 323-361-3963
• Email: hwiseman[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Ischemia
• Hemodynamic Instability
• HIE
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• TBI
• TBI (Traumatic Brain Injury)

Intervention

Diagnostic Test:
• MR Imaging
MR imaging pertaining to the patient and project (ICHOR 1)

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.