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

NCT05644340 | Completed

• 1 other identifier: 2019/154
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

pediatric anesthesia; metabolic flow anesthesia; low flow anesthesia

Outcome Measures

Primary Outcomes (1)

• Total amount of sevoflurane consumed

  At the end of the surgery, total amount of sevoflurane, which is indicated on the anesthesia machine screen, will be recorded in milliliters

  up to 3 hours

Secondary Outcomes (3)

• Time to extubation after inhalation anesthesia stop

  Up to 45 minutes

• Time to cooperation after inhalation anesthesia stop

  Up to 2 hours

• Delta Oxygen Concentration

  up to 2 hours

Study Arms (2)

Automated Gas Flow Group using speed 8 to reach targeted end-tidal sevoflurane concentration

ACTIVE COMPARATOR

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.

Procedure: Speed 8 (Fast balancing gas flow)

Automated Gas Flow Group using speed 4 to reach targeted sevoflurane concentration

ACTIVE COMPARATOR

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.

Procedure: Speed 4 (Medium speed balancing gas flow)

Interventions

Speed 8 (Fast balancing gas flow) PROCEDURE

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.

Automated Gas Flow Group using speed 8 to reach targeted end-tidal sevoflurane concentration

Speed 4 (Medium speed balancing gas flow) PROCEDURE

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.

Automated Gas Flow Group using speed 4 to reach targeted sevoflurane concentration

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Emergency surgery
• Patients who are contraindicated for inhalation anesthesia

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 9, 2022
• Study Start: December 16, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

TU (1)