NCT03465319

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

February 27, 2018

Last Update Submit

March 14, 2018

Conditions

Anesthesia

Keywords

oxygen concentrationvolatile anesthetics concentrationprediction model

Outcome Measures

Primary Outcomes (1)

  • Prediction Error

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

    20 minutes period (data collection every 2 seconds)

Study Arms (2)

Sevoflurane

10 patients receiving an anesthesia with sevoflurane

Desflurane

10 patients receiving an anesthesia with desflurane

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients of the surgical department.

You may qualify if:

  • patients undergoing an operation under general anesthesia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Erlangen, Bavaria, 91054, Germany

Location

Study Officials

  • Tino Muenster, Prof. Dr. med.

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director of the Department of Anaesthesiology

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 14, 2018

Study Start

December 15, 2015

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)