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AnesthesiaFGF 03NCT07628231

Assessment of Sevoflurane Consumption During General Anesthesia With a Low Fresh Gas Flow Rate of 0.3 L/Min

An observational study of Anesthesia, run by Centre Hospitalier Universitaire de Nīmes.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Driven by industry demands and the need for anesthesia that consumes fewer resources ("green anesthesia"), manufacturers of anesthesia ventilators have developed closed-circuit ventilators. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia
What is being tested?
None, Pure observatinal study
How many people
30 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent general anesthesia with ventilation at a minute volume of 0.3 L/min at the Nîmes University Hospital

Who may be able to join

  • Adult patients undergoing surgery under general anesthesia with mechanical ventilation
  • Connected to a ventilator linked to the Carestaion software
  • No refusal as indicated by a letter of consent

Who cannot join

  • Refusal to participate
  • Minor patients

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Philippe CUVILLON, PU-PH contact

+ 33 4.66.68.30.50

philippe.cuvillon@chu-nimes.fr

About this study

Driven by industry demands and the need for anesthesia that consumes fewer resources ("green anesthesia"), manufacturers of anesthesia ventilators have developed closed-circuit ventilators. In a closed-circuit system, during the exhalation phase, gases are not released outside the ventilator into the atmosphere but are injected into the inspiratory limb of the circuit after being warmed and having CO2 removed. It is a closed loop. However, the loop is not completely closed because a very small stream of air is additionally injected into the inspiratory limb to limit the risk of hypoxia. This small stream of air is called "Fresh Gas Flow" or FGF.

To optimize this closed-loop recirculation, manufacturers have designed machines capable of minimizing the fresh gas flow. In the 2000s, machines operated with FGFs of 2 L/min, dropping to flows as low as 0.5 L/min by 2010. This low-flow regime allows for an 80% reduction in halogenated gas (sevoflurane) consumption while maintaining the same efficiency. Recently, even more sophisticated machines have been designed with FGFs of 0.3 L/min. Some of these new machines will be commercially available on a large scale in 2026. As part of an industrial partnership, the Nîmes University Hospital has validated the post-CE marking of these machines for certain manufacturers (including General Electric); the post-CE marking allows the manufacturer to have access to usage data Given that this product has only recently been introduced to the market, very little data has been published on the use of sevoflurane in daily practice at very low FGF flow rates (0.3 to 0.5 L/min).

Read more

For the past four months, the Nîmes University Hospital has had two CE-marked machines (GE, CS 850) capable of ventilating at flow rates of 0.3 L/min. These machines are connected to software (Carestation Insight) that allows all anonymized ventilator data to be recorded independently of the users. This software has been in continuous use in 12 operating rooms since 2024 within our institution and has been the subject of numerous publications (see Ref. 19). All ventilation and sevoflurane data are continuously recorded and stored in a secure, anonymous cloud (Ref. 19).

The objective of this retrospective study is to analyze the database of sevoflurane consumption derived from the Carestation Insight software for patients who underwent general anesthesia with ventilation at FGF flow rates of 0.3 L/min and to compare these data with our database of patients under anesthesia at flow rates of 0.5 to 2 L/min, also derived from this same cloud.

Conditions
Anesthesia
Being tested
None, Pure observatinal study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None, Pure observatinal studyOther

    None, Pure observatinal study

Study groups in NCT07628231
Study groupRoleWhat they receive
FGF flow rates of 0.3Patients who underwent general anesthesia with mechanical ventilation at a minute ventilation of 0.3
Receives: Other: None, Pure observatinal study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sevoflurane consumption

    Measurement of sevoflurane consumption (in liters) per minute of anesthesia

    Measured: Perioperative

  2. FGF

    Measurement of gas flow rate (FGF) (L/minute).

    Measured: Perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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-control
Time perspective
Retrospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628231
Sponsor's protocol ID
Local/2026/PC-01
Acronym
FGF 03
Status last verified
May 2026
First submitted
28 May 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Centre Hospitalier Universitaire de Nīmes.

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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe CUVILLON, PU-PH (+ 33 4.66.68.30.50, philippe.cuvillon@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sevoflurane consumption (time frame: Perioperative). The study lists 2 primary outcomes in all. 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 4 Jun 2026.

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