- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07628231
Assessment of Sevoflurane Consumption During General Anesthesia With a Low Fresh Gas Flow Rate of 0.3 L/Min (FGF 03)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Philippe CUVILLON, PU-PH
- Phone Number: + 33 4.66.68.30.50
- Email: philippe.cuvillon@chu-nimes.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Refusal to participate
- Minor patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
FGF flow rates of 0.3
Patients who underwent general anesthesia with mechanical ventilation at a minute ventilation of 0.3
|
None, Pure observatinal study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sevoflurane consumption
Time Frame: Perioperative
|
Measurement of sevoflurane consumption (in liters) per minute of anesthesia
|
Perioperative
|
|
FGF
Time Frame: Perioperative
|
Measurement of gas flow rate (FGF) (L/minute).
|
Perioperative
|
Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Local/2026/PC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Aligarh Muslim UniversityCompletedAnesthesia | Anesthesia Intubation Complication | Anesthesia; Adverse EffectIndia
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
University Health Network, TorontoActive, not recruiting
-
University of PecsCompleted
-
Hormozgan University of Medical SciencesUnknownAnesthesia | Anesthesia; FunctionalIran, Islamic Republic of
-
Ankara City Hospital BilkentCompletedAnesthesia | Sedation | Anesthesia, Intravenous | Sedation Complication | Recovery From Anesthesia | Monitoring of Depth of AnesthesiaTurkey (Türkiye)
-
Children's Hospital Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingAnesthesia | Anesthesia; ReactionUnited States
Clinical Trials on None, Pure observatinal study
-
Centre Hospitalier Universitaire de NīmesNot yet recruiting
-
Centre Hospitalier Universitaire de NīmesCompletedStroke | Hemorrhage | Cerebral Amyloid AngiopathyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedStroke | Stenoses, CarotidFrance
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingCerebral Hemorrhage | Acute Lobar Haematoma
-
Centre Hospitalier Universitaire de NīmesCompletedCerebral Amyloid Angiopathy | Hypertensive ArteriopathyFrance
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedCerebral Amyloid Angiopathy | SiderosisFrance
-
Centre Hospitalier Universitaire de NīmesWithdrawnChronic Inflammatory Demyelinating PolyradiculoneuropathyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedCerebellar AtaxiaFrance
-
Centre Hospitalier Universitaire de NīmesTerminated