Anesthesia vs Aviation: Does Added Carbon Dioxide in Normobaric Hypoxia Have the Same Effect on Cerebral Oxygenation as in Hypobaric Hypoxia?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to decrease of tissue oxygenation index by 20 %
研究概览
简要总结
Several projects in high altitude research in environments with a low oxygen partial pressure (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral performance could be improved by adding C02 (cabon dioxide).
The investigators hypothesize that adding 5% C02 to 02 (Oxygen) also under normobaric conditions increases the time until a significant cerebral hyopxia is measured by near infrared spectroscopy (NIRS) compared to the administration of 95% 02.
lf this hypothesis proves to be true, this approach might be used in situations in which individuals are prone to cerebral hypoxia. In bariatric surgery, patients that experience an apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher body mass index (BMI) leading to a reduced functional residual capacity (FRC), which serves as the oxygen reserve in the body.
详细描述
On the day of surgery patients will be randomized. After induction of anesthesia and endotracheal intubation patients will be managed by the study team to perform the intervention and the measurements.
According to randomization, investigational medical product (IMP) or comparator will be administrated by ventilator 1/ventilator 2.
At time point 1 apnea will be performed by disconnecting the ventilator from the endotracheal tube until the NIRS value has dropped by 20% from baseline. After that, re-ventilation will be resumed immediately, until parameters have returned to baseline.
During apnea time NIRS and vital signs will be recorded permanently, blood samples will be drawn at definite time points.
Application of IMP (or comparator) will be performed in this cross-over study design in the same manner after the baseline level is reached again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The sequence whether the IMP or the comparator is applied first will be randomly assigned using the web-based randomizer.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are designated for bariatric surgery at the University Hospital Zurich (USZ)
- •Informed Consent as documented by signature
- •BMI >35 kg/m2
排除标准
- •Severe end-organ damage: chronic obstuctive pulmonary disease (COPD) GOLD (cassification) III and IV, known hepatic insufficiency or elevated liver enzymes, renal creatinine clearance <30ml/min
- •Severe cardiovascular disease (NYHA classification III and IV)
- •Known pulmonary Hypertension
- •Cerebrovascular disease
- •Pregnancy and lactation
- •Cardiac dysrhythmias
- •acidosis, chronic pulmonary disease
- •Known or suspected non-compliance, drug or alcohol abuse
研究组 & 干预措施
Oxycarbon (5% CO2 + 95% O2)
Patients will be mechanical ventilated with Oxycarbon (5%CO2 +95% O2) after normocapnia is reached until FeO2 is stable for at least 1 min ≥ 80%. At timepoint 1 immediately prior apnea NIRS and vital parameters will be registered and an bloodsample will be drawn.
干预措施: Oxycarbon (5% CO2+ 95% O2) (Drug)
Control (95% O2)
Same procedure as arm "active comparator"
干预措施: Oxycarbon (5% CO2+ 95% O2) (Drug)
结局指标
主要结局
Time to decrease of tissue oxygenation index by 20 %
时间窗: 1 Day
Parameter will be measured by NIRS
次要结局
- PCO2 ( partial pressure of carbon)(1Day)
- PaO2 (Oxygen partial pressure)(1 Day)
- SpO2 (oxygen saturation)(1 Day)