A Comparison Between the Aysis® Cs2 (General Electrics) Ventilator in EtControl® Mode and the Perseus® A 500 (Dräger) in VaporView® Mode on Maniability and Consumption of Desflurane (ConsoHalo)

April 27, 2015 updated by: Bonnot, Saint Antoine University Hospital

The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.

The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.

The goal of this work was to compare the maniability of the intraoperative administered concentrations and the consumption of Desflurane between these 2 modalities of administration.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ASA 1/2 adult patients undergoing a general anesthesia of more than one hour.

Description

Inclusion Criteria:

  • patients undergoing a general anesthesia for intra abdominal surgery during more than one hour
  • ASA 1or 2

Exclusion Criteria:

  • contraindication to halogenated agent
  • thoracic surgery
  • no french speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Perseus
Use of Perseus® A 500 with VaporView® mode that gives the evolution of inspired (Fi) and end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to maintain a low FGF (0.5 L/min)
Aysis
Use of Aysis® Cs2 ventilator with automated control of end-tidal inhalation anesthetic concentration, EtControl® mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumption of Desflurane between these 2 modalities of administration.
Time Frame: Time of general anesthesia (1h minimum up to 12h)
Des consumption was measured by micrometric weighing of the vaporizer before and after general anesthesia and a milliliter per min consumption was calculated
Time of general anesthesia (1h minimum up to 12h)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution
Time Frame: Time of general anesthesia (1h minimum up to 12h)
Time of general anesthesia (1h minimum up to 12h)
Anesthesia depth monitoring by BIS
Time Frame: Time of general anesthesia (1h up to 12h)
Time of general anesthesia (1h up to 12h)
Hemodynamic stability
Time Frame: Time of general anesthesia (1h minimum up to 12h)

Number of cardiovascular event which required an intervention

  • Vasopressive drug
  • Antihypertensive drug
  • modification of the Desflurane end-tidal (Fe) fraction
Time of general anesthesia (1h minimum up to 12h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Antoine University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01476-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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