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Feasibility and Safety Properties of Metabolic Flow Anesthesia Driven by Automated Gas Control in Pediatric Patients

Feasibility and Safety Properties of Metabolic Flow Anesthesia Driven by Automated Gas Control in Pediatric Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05644340
Enrollment
130
Registered
2022-12-09
Start date
2022-12-16
Completion date
2023-04-10
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

pediatric anesthesia, metabolic flow anesthesia, low flow anesthesia

Brief summary

Low flow anesthesia was considered to be causing rebreathing, hypoxia and hypercarbia in the past. However, developing technologies made anesthesia ventilators safer. Low flow anesthesia is proved to be safe and cost-effective for almost a decade, and newer anesthetic machines with automated gas flow and metabolic flow anesthesia (\<0.3 L/min gas flow) features are now becoming prominent. The literature still lacks of pediatric data regarding the cost analysis and safety profile of low flow and especially in metabolic flow anesthesia. In this study, it is aimed to observe inhaled agent expenditure of automated gas flow anesthesia which reaches metabolic flow limits in pediatric patients. For that, automated gas flow will be set to provide a desired end-tidal sevoflurane concentration during general anesthesia. Accordingly, inspired fraction of oxygen and air values will be recorded in 15-minute intervals. Primary outcome will be the inhaled agent (sevoflurane) amount wasted in milliliters for both inhaled agent maintenance speed (8-fast and 4-slow). Secondarily, delta value of set and detected inspired fraction of oxygen (DeltaFiO2=DetectedFiO2-SetFiO2) will be analyzed. DeltaFiO2 higher than 5 units will be accepted as unsafe gas mixture, and the incidence will be evaluated. Secondary outcomes will also include duration of emergence from anesthesia including both extubation and obeying verbal commands.

Interventions

PROCEDURESpeed 8 (Fast balancing gas flow)

General anesthesia will be induced via intravenous agents, and anesthesia maintenance will be provided via inhalation for all the patients. The maintenance will be provided with sevoflurane using automated gas flow with the selected speed of 8. The anesthesia machine indicates amount of sevoflurane inhaled, inspired and exhaled oxygen, carbon dioxyde, air and sevoflurane concentrations. Accordingly these data and actual flow rate will be recorded every 15 minutes.

PROCEDURESpeed 4 (Medium speed balancing gas flow)

General anesthesia will be induced via intravenous agents, and anesthesia maintenance will be provided via inhalation for all the patients. The maintenance will be provided with sevoflurane using automated gas flow with the selected speed of 4 (Medium speed). The anesthesia machine indicates amount of sevoflurane inhaled, inspired and exhaled oxygen, carbon dioxyde, air and sevoflurane concentrations. Accordingly these data and actual flow rate will be recorded every 15 minutes.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric surgery patients * Elective or Semielective surgeries * Patients suitable for inhalation anesthesia

Exclusion criteria

* Emergency surgery * Patients who are contraindicated for inhalation anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Total amount of sevoflurane consumedup to 3 hoursAt the end of the surgery, total amount of sevoflurane, which is indicated on the anesthesia machine screen, will be recorded in milliliters

Secondary

MeasureTime frameDescription
Time to extubation after inhalation anesthesia stopUp to 45 minutesTime between the inhalation anesthesia stop and extubation in minutes
Time to cooperation after inhalation anesthesia stopUp to 2 hoursTime between the inhalation anesthesia stop and cooperation to verbal impulses in minutes
Delta Oxygen Concentrationup to 2 hoursThe adjusted oxygen fraction (generally 40%) minus the actual inhaled oxygen fraction will provide the delta value. The data will be recorded every 15-minute during the surgery, and delta \>%5 will be considered as unsafe

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026