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

NCT05644340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-04-11

No results posted yet for this study

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.

Conditions

  • Anesthesia

Interventions

PROCEDURE

Speed 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.

PROCEDURE

Speed 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 & Collaborators

  • Istanbul University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2023-04-10
Completion
2023-04-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644340 on ClinicalTrials.gov