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临床试验/NCT03465319
NCT03465319已完成不适用

Studie Zur Evaluation Der Narkosemittel- Und Sauerstoffkonzentrationsvorhersage im Narkosegeraet Perseus-A500 Der Firma Draeger

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Prediction Error

研究概览

简要总结

The anesthesia machine "Draeger Perseus A 500" has an integrated software which calculates the predicted course of the concentration of oxygen and the volatile anesthetics sevoflurane and desflurane for the next 20 minutes.

The Goal of this study was to evaluate the accuracy of this prediction under controlled clinical circumstances.

Therefore 20 patients undergoing an operation with general anesthesia were included. They were assigned to a sevoflurane- or desflurane-group by lots.

The oxygen- and volatile anesthetic influx into the anesthesia machine's circuit was adjusted following a fixed protocol. The concentration of oxygen and the volatile anesthetic was measured and compared to the predicted values.

详细描述

In an anesthesia machine´s circuit the concentration of oxygen and volatile anesthetics depends on many variables. Especially during low- or minimal-flow anesthesia it can be difficult for the anesthesist to anticipate these values.

In the anesthesia machine 'Draeger Perseus A500' a software is included, which calculates and predicts the course of the inspired and exhaled concentration of oxygen and the volatile anesthetics sevoflurane and desflurane for the next 20 minutes. The results can be displayed as a diagram and are based on the actual setup of the anesthesia machine.

The behavior of the oxygen-concentration depends on the oxygen-delivery on the one hand and on the patients oxygen-consumption on the other hand. The oxygen delivery into the anesthesia-circuit can be analysed easily and exactly. The patients oxygen-consumption cannot be measured except invasive procedures such as a pulmonary-catheter are used. In daily routine the oxygen-consumption can only be calculated. Different methods based on the Brody-equation are published. In the Perseus-software a simplified formula suggested by Arndt ist used.

The concentration-progress of volatile anesthetics depends on many factors and can be described as a cascade of systems beginning with the influx of gas into the anesthesia machine, the uptake or release of the anesthetic agent in the alveoli and ending with the distribution between the different compartments and possibly the metabolisation. These processes can be described by pharmacologic more-compartment models. In the Perseus anesthesia machine a five-compartment model described by Bailey is used for predicting.

These two models have never before been included into the software of an anesthesia machine an therefore never been evaluated ind such a surrounding.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing an operation under general anesthesia

排除标准

  • body-mass-index > 35 kg/m2
  • pregnancy
  • patients who are not able to give informed consent
  • patients with relevant comorbidity (ASA-classification > II), especially cardio-vascular or pulmonary disease
  • contraindications for volatile anesthetics (for example disposition for malignant hyperthermia)

结局指标

主要结局

Prediction Error

时间窗: 20 minutes period (data collection every 2 seconds)

median prediction error (%) and median absolut prediction error (%) for the concentration of oxygen- and volatile anesthetics

次要结局

未报告次要终点

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tino Münster

Vice director of the Department of Anaesthesiology

University of Erlangen-Nürnberg Medical School

研究点 (1)

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