Online Noninvasive Assessment of Human Brain Death and Deep Coma by Near-infrared Spectroscopy With Protocol at Varied Fraction of Inspired O2
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Δ[HbO2]
研究概览
简要总结
This study aims to assess brain death and deep coma with the self-made near infrared spectroscopy (NIRS) instrument. The investigators used the noninvasive method to monitor the Δ[HbO2] (the concentration changes in oxy-hemoglobin) and Δ[Hb] (the concentration changes in deoxy-hemoglobin) in the region around the forehead of medically evaluated participating patients and healthy subjects. 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, while deep coma is a profound state of unconsciousness associated with depressed cerebral activity. Timely distinguishing the two states is crucial for saving patients. The noninvasive, sensitive, universally available, and timely ancillary method to assess brain death and deep coma has not been established. This study aims to explore a noninvasive and straightforward way in brain death and deep coma online assessment. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy instrument attached on the forehead of participators. A multiple-phase protocol at varied fraction of inspired O2(FIO2) were utilized during the assessment. Then the investigators compared the multiple physiological parameters changes among different groups at different FIO2.
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
- 是
入选标准
- •Patients who have had brain death or serious brain trauma.
- •Patients who have deep coma with autonomous respiration according to GCS coma Scale
- •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
Ting Li
Full professor
Chinese Academy of Medical Sciences