Evaluation of the Concentration-prediction for Oxygen and Volatile Anesthetic Agents in the 'Draeger Perseus A500' Anesthesia Machine
NCT ID: NCT03465319
Last Updated: 2018-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2015-12-15
2017-01-10
Brief Summary
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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.
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Detailed Description
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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.
For the evaluation the investigators included 20 patients from the surgical department undergoing an operation with general anesthesia. 10 patients received sevoflurane, 10 patients desflurane.
The investigators generated stable conditions to evaluate the precision of these predictions. Thus the investigators used a fixed protocol for the gas influx to the anesthesia machine, the vapor adjustment and the ventilator setup. At least three periods lasting 20 minutes were measured.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Sevoflurane
10 patients receiving an anesthesia with sevoflurane
No interventions assigned to this group
Desflurane
10 patients receiving an anesthesia with desflurane
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
20 Years
60 Years
ALL
No
Sponsors
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Drägerwerk AG & Co. KGaA
INDUSTRY
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Tino Münster
Vice director of the Department of Anaesthesiology
Principal Investigators
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Tino Muenster, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology
Locations
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University Hospital
Erlangen, Bavaria, Germany
Countries
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Other Identifiers
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PersA500-PM
Identifier Type: -
Identifier Source: org_study_id
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