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.
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.
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 group | Role | What they receive |
|---|---|---|
| FGF flow rates of 0.3 | Patients 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.
sevoflurane consumption
Measurement of sevoflurane consumption (in liters) per minute of anesthesia
Measured: Perioperative
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.
- First posted4 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sevoflurane Consumption During General Anesthesia With a Low Fresh Gas Flow Rate of 0.3 L/Min
- ClinicalTrials.gov ID
- NCT07628231
- Acronym / sponsor ID
- FGF 03 / Local/2026/PC-01
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- 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.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FGF flow rates of 0.3 | – | Other: None, Pure observatinal studyPatients who underwent general anesthesia with mechanical ventilation at a minute ventilation of 0.3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- Adult patients undergoing surgery under general anesthesia with mechanical ventilation
Key exclusion criteria (2 listed)
- Refusal to participate
- Minor patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, Pure observatinal studyNone, Pure observatinal study | Other | FGF flow rates of 0.3 |
Primary outcome
sevoflurane consumption
Time frame: Perioperative
Measurement of sevoflurane consumption (in liters) per minute of anesthesia
FGF
Time frame: Perioperative
Measurement of gas flow rate (FGF) (L/minute).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
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.