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临床试验/NCT06195345
NCT06195345招募中不适用

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

Children's Hospital Los Angeles2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Change in cerebral blood flow (ml blood/100g/min)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who are able to tolerate an MRI.
  • Are patients scheduled for a clinically indicated MRI.
  • Between birth and up to 18 years.

排除标准

  • 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.

研究组 & 干预措施

Pediatric Patients

Children scheduled for clinical MR imaging.

干预措施: MR Imaging (Diagnostic Test)

结局指标

主要结局

Change in cerebral blood flow (ml blood/100g/min)

时间窗: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.

Phase contrast (PC) acquisition via MRI will be used to assess any impact of anesthesia on cerebral blood flow.

Change in cerebral metabolic rate of oxygen (ml O2/100g/min)

时间窗: Time points over which the change is assessed: change from (1) start of MRI, through (2) MRI completion, an average of 60 minutes.

T2 relaxation under spin tagging (TRUST) acquisition via MRI will be used to assess any impact of anesthesia on cerebral metabolic rate of oxygen.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Borzage

Principal Investigator

Children's Hospital Los Angeles

研究点 (2)

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