Anesthetics AgentConsoHaloNCT02427971
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
An observational study of Anesthetics Agent and Consumption, run by Saint Antoine University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthetics Agent, Consumption, Inhalation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Apr 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA 1/2 adult patients undergoing a general anesthesia of more than one hour.
Who may be able to join
- patients undergoing a general anesthesia for intra abdominal surgery during more than one hour
- ASA 1or 2
Who cannot join
- contraindication to halogenated agent
- thoracic surgery
- no french speaking
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint-Antoine
Paris
Christophe Gutton, christophe.gutton@sat.aphp.fr
About this study
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.
- Conditions
- Anesthetics Agent, Consumption, Inhalation, Desflurane
- Medical subject headings
- Respiratory Aspiration
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time of general anesthesia (1h minimum up to 12h)
Secondary outcomes (3)
Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution
Measured: Time of general anesthesia (1h minimum up to 12h)
Anesthesia depth monitoring by BIS
Measured: Time of general anesthesia (1h up to 12h)
Hemodynamic stability
Number of cardiovascular event which required an intervention
- Vasopressive drug
- Antihypertensive drug
- modification of the Desflurane end-tidal (Fe) fraction
Measured: Time of general anesthesia (1h minimum up to 12h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics AgentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Antoine University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnot, Saint Antoine University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427971
- Sponsor's protocol ID
- 2014-A01476-41
- Acronym
- ConsoHalo
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02427971
- Acronym / sponsor ID
- ConsoHalo / 2014-A01476-41
- Conditions
- Anesthetics Agent, Consumption, Inhalation, Desflurane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saint Antoine University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1/2 adult patients undergoing a general anesthesia of more than one hour.
Key inclusion criteria (2 listed)
- patients undergoing a general anesthesia for intra abdominal surgery during more than one hour
- ASA 1or 2
Key exclusion criteria (3 listed)
- contraindication to halogenated agent
- thoracic surgery
- no french speaking
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
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
3 secondary outcomes
Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution
Time frame: Time of general anesthesia (1h minimum up to 12h)
Anesthesia depth monitoring by BIS
Time frame: Time of general anesthesia (1h up to 12h)
Hemodynamic stability
Time frame: Time of general anesthesia (1h minimum up to 12h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
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 Anesthetics Agent and Consumption, run by Saint Antoine University Hospital at 1 site in France.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 2015. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of Desflurane between these 2 modalities of administration. (time frame: Time of general anesthesia (1h minimum up to 12h)). 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 28 Apr 2015.