NCT02427971

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

April 15, 2015

Last Update Submit

April 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Consumption of Desflurane between these 2 modalities of administration.

    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 Outcomes (3)

  • Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution

    Time of general anesthesia (1h minimum up to 12h)

  • Anesthesia depth monitoring by BIS

    Time of general anesthesia (1h up to 12h)

  • Hemodynamic stability

    Time of general anesthesia (1h minimum up to 12h)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint-Antoine

Paris, France

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 28, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations