跳至主要内容
临床试验/NCT03864887
NCT03864887Unknown不适用

Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Δ[HbO2]

研究概览

简要总结

This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

详细描述

Brain death is an irreversible loss of all brain functions, and the assessment is crucial for organ supply for transplantation. The noninvasive, sensitive, universally available and timely ancillary method to assess brain death has not been established. This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment. The concentration changes ratios of oxyhemoglobin to deoxyhemoglobin (Δ[HbO2]/Δ[Hb]) in the cerebral cortex of brain-dead patients were significantly higher than those of healthy subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have had brain death or serious brain trauma.
  • Healthy people who are interested in optical assessment of hemodynamic parameters

排除标准

  • Patients who are in pregnancy or have plan to conception.
  • Patients who have vertebra surgery or have plan of surgery.
  • Patients who are inappropriate to join this trial judged by the radiologists or specialists.
  • AIDS, Active Hepatitis, Tuberculosis, Syphilis
  • Patients who regularly take anticoagulants, antiplatelet drugs

结局指标

主要结局

Δ[HbO2]

时间窗: 1 day during the whole experiment

The changes of oxyhemoglobin concentrations in prefrontal cortex.

Δ[Hb]

时间窗: 1 day during the whole experiment

The changes of deoxyhemoglobin concentrations in prefrontal cortex.

次要结局

  • Heart rate(1 day during the whole experiment)
  • Blood pressure(1 day during the whole experiment)

研究者

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

Ting Li

Professer

Chinese Academy of Medical Sciences

研究点 (1)

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