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Completed

NCT Number: NCT03465319

Evaluation of the Concentration-prediction for Oxygen and Volatile Anesthetic Agents in the 'Draeger Perseus A500' Anesthesia Machine

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Erlangen, Bavaria, 91054, Germany

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing an operation under general anesthesia

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Prediction Error

    Time frame: 20 minutes period (data collection every 2 seconds)

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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Drägerwerk AG & Co. KGaA

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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