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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Speed 4 (Medium speed balancing gas flow); Procedure: Speed 8 (Fast balancing gas flow)

• Registration Number: NCT05644340
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Study Start: 2022-12-16
• Status Verified: 2023-04
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Gas Flow Group using speed 4 to reach targeted sevoflurane concentration	Speed 4 (Medium speed balancing gas flow)	Pediatric patients who are operated under general anesthesia using automated gas flow which is set to speed 4 to achieve targeted end-expiratory sevoflurane concentration (MAC 1.2) will be included in the study. Automated gas flow provides a gas mixture in different proportions which is automatically generated and consists of sevoflurane, oxygen and air. Inspired and end-tidal concentrations of sevoflurane, oxygen and air will be available on the anesthesia ventilator screen which will be recorded accordingly in15-minute intervals.
Automated Gas Flow Group using speed 8 to reach targeted end-tidal sevoflurane concentration	Speed 8 (Fast balancing gas flow)	Pediatric patients who are operated under general anesthesia using automated gas flow which is set to speed 8 to achieve targeted end-expiratory sevoflurane concentration (MAC 1.2) will be included in the study. Automated gas flow provides a gas mixture in different proportions which is automatically generated and consists of sevoflurane, oxygen and air. Inspired and end-tidal concentrations of sevoflurane, oxygen and air will be available on the anesthesia ventilator screen which will be recorded accordingly in15-minute intervals.

Primary Outcome Measures

Name	Time	Method
Total amount of sevoflurane consumed	up to 3 hours	At the end of the surgery, total amount of sevoflurane, which is indicated on the anesthesia machine screen, will be recorded in milliliters

Secondary Outcome Measures

Name	Time	Method
Time to extubation after inhalation anesthesia stop	Up to 45 minutes	Time between the inhalation anesthesia stop and extubation in minutes
Time to cooperation after inhalation anesthesia stop	Up to 2 hours	Time between the inhalation anesthesia stop and cooperation to verbal impulses in minutes
Delta Oxygen Concentration	up to 2 hours	The 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"

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey