Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals who are able to tolerate an MRI.
Are patients scheduled for a clinically indicated MRI.
Between birth and up to 18 years.
Disqualifiers
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.
Trial population
Neonates and young children
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MR Imaging
Diagnostic testMR imaging pertaining to the patient and project (ICHOR 1)
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Pediatric Patients1 intervention
Trial outcomes
Primary outcomes
1
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 frame
Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.2
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 frame
Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov