Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ScO2 (NIRS-measured cerebral oxygen saturation)
研究概览
简要总结
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years) patients
- •Elective craniotomy
排除标准
- •Repeat craniotomy
- •Preoperative hypotension (defined as systolic blood pressure below 110 mmHg)
- •Preoperative hypoxia (defined as peripheral oxygen saturation (SpO2) < 90% without oxygen supplementation before surgery)
- •No negative pregnancy test for women <50 years.
研究组 & 干预措施
One strategy for all enrolled patients:
All patients will participate in three substudies, in which they also act as controls, with exposure to the same three interventions: 1) NIRS-measurement on skin, skull and dura, 2) Phenylephrine 0.1 mg iv., and 3) inspired oxygen fraction of 0.3 vs. 0.8
干预措施: NIRS measurements on skin, skull and dura (Device)
One strategy for all enrolled patients:
All patients will participate in three substudies, in which they also act as controls, with exposure to the same three interventions: 1) NIRS-measurement on skin, skull and dura, 2) Phenylephrine 0.1 mg iv., and 3) inspired oxygen fraction of 0.3 vs. 0.8
干预措施: Phenylephrine's effect on brain oxygenation (Drug)
One strategy for all enrolled patients:
All patients will participate in three substudies, in which they also act as controls, with exposure to the same three interventions: 1) NIRS-measurement on skin, skull and dura, 2) Phenylephrine 0.1 mg iv., and 3) inspired oxygen fraction of 0.3 vs. 0.8
干预措施: Normal vs. high inspired oxygen (Drug)
结局指标
主要结局
ScO2 (NIRS-measured cerebral oxygen saturation)
时间窗: During surgical procedure
Difference in ScO2 between dura and skin (Primary analysis for substudy 1)
次要结局
- PBrO2 (Partial pressure of brain tissue oxygen)('Normoxia' is induced with FiO2 = 0.30 for 5 minutes, and then changed to 'Hyperoxia' with FiO2 = 0.80 for the subsequent 5 minutes, while registering the Licox-signal.)
- ScO2 (NIRS-measured cerebral oxygen saturation)(Measurements will be performed as the surgeon exposes the skull.)
- ScO2 (NIRS-measured cerebral oxygenation)(NIRS signal is obtained continuously during the Phenylephrine intervention)
研究者
Sofie Pedersen
MD, Primary Investigator
University Hospital Bispebjerg and Frederiksberg