Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- amount of p50 in different levels of hypercapnia and hypothermia
研究概览
简要总结
In an avalanche burial with an air pocket hypercapnia (and hypoxia) develops within few minutes, hypercapnia increases the rate of cooling and therefore the development of hypothermia. The Triple H Syndrome (Hypoxia, Hypercapnia, Hypothermia) occurs. This specific combination of the three parameters is unique for avalanche burial with an air pocket. Every single parameter has a substantial effect on the hemoglobin-oxygen dissociation curve, but until now no study described the combination of these three parameters. This curve will be measured under these specific conditions in a specifically developed in vitro model, to quantify its shifts and to show if there are combined effects of pCO2 and temperature. The newly developed method will be validated in comparison with an established method. The project will be performed with whole blood, drawn by healthy volunteers, in an experimental setting. The samples will be blinded to the investigator and analyzed in a randomized manner.
详细描述
The ODC is a function of pO2 and SO2. pO2, the independent variable, is plotted on the x axis, SO2 on the y axis. For the determination of this function, a pairwise measurement of pO2 and the corresponding SO2 is to be performed. Using nonlinear regression analysis, the ODC can be fitted to the measured points that describe the relation of pO2 and SO2 and characteristic parameters like p50 value and inflection points can be calculated.
To measure the ODC under the conditions of the Triple H Syndrome (Hypoxie, Hypercapnia, Hypothermia), the temperature and the pCO2 have to be changed and controlled during the measurement. No commercially available instrument is able to obtain this. Therefore, we envisaged the development of an entirely new approach.
In the 3H ODC trial venous blood will be drawn from 18 - 40 years old female and male volunteers by a unique venipuncture. The participants have to be in a fasted situation, ASA I and nonsmokers. The blood sample will be immediately pseudonymized and stored on ice and a venous blood gas analysis will be carried out (pH, Hb, COHb, MetHb, FHb). Simultaneous to the main measurement, 2,3 BPG will be quantified by an ELISA test and any unknown hemoglobinopathy will be excluded by Hemoglobin Electrophoresis. In the 3H ODC trial 4 different pCO2 levels and 4 different temperatures will be analyzed in the resulting 16 combinations. In each round a lot of ODCs will be measured, the measurement chamber will be filled with participants blood samples in a randomized manner. After the measurements, the blood samples will be discarded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •fasted situation
- •Informed Consent
排除标准
- •any drug abuse
- •any drug intake within the last 10 days
- •known hemoglobinopathy
- •relevant illness within last 14 days
- •relevant blood loss within last 14 days
- •pregnancy or breast-feeding
- •participation in any pharmacological study
- •exposure to high altitude (> 3000 m) within last 4 weeks
结局指标
主要结局
amount of p50 in different levels of hypercapnia and hypothermia
时间窗: day 1
amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)
次要结局
- amount of p50 shift due to sex(day 1)
- amount of inflection point in different levels of hypercapnia and hypothermia(day 1)