AnesthesiaNCT03465319
Evaluation of the Concentration-prediction for Oxygen and Volatile Anesthetic Agents in the 'Draeger Perseus A500' Anesthesia Machine
An observational study of Anesthesia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2015to 10 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Consecutive patients of the surgical department.
Who may be able to join
- patients undergoing an operation under general anesthesia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studie Zur Evaluation Der Narkosemittel- Und Sauerstoffkonzentrationsvorhersage im Narkosegeraet Perseus-A500 Der Firma Draeger
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anesthesia
- Keywords
- oxygen concentration, volatile anesthetics concentration, prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | 10 patients receiving an anesthesia with sevoflurane | |
| Desflurane | 10 patients receiving an anesthesia with desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction Error
median prediction error (%) and median absolut prediction error (%) for the concentration of oxygen- and volatile anesthetics
Measured: 20 minutes period (data collection every 2 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Dec 2015
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Drägerwerk AG & Co. KGaA
- Responsible party
- Principal investigator, Tino Münster, University of Erlangen-Nürnberg Medical School
- Investigators
- Tino Muenster, Prof. Dr. med., Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465319
- Sponsor's protocol ID
- PersA500-PM
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studie Zur Evaluation Der Narkosemittel- Und Sauerstoffkonzentrationsvorhersage im Narkosegeraet Perseus-A500 Der Firma Draeger
- ClinicalTrials.gov ID
- NCT03465319
- Acronym / sponsor ID
- PersA500-PM
- Conditions
- Anesthesia
- Keywords
- oxygen concentration, volatile anesthetics concentration, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Drägerwerk AG & Co. KGaA
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | –10 patients receiving an anesthesia with sevoflurane |
| Desflurane | – | –10 patients receiving an anesthesia with desflurane |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Consecutive patients of the surgical department.
Key inclusion criteria (1 listed)
- patients undergoing an operation under general anesthesia
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tino Muenster, Prof. Dr. med. principal investigator
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction Error (time frame: 20 minutes period (data collection every 2 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.