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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644340
• Other study ID #: 2019/154
• Status: Completed
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to extubation after inhalation anesthesia stop	Time between the inhalation anesthesia stop and extubation in minutes	Up to 45 minutes
Secondary	Time to cooperation after inhalation anesthesia stop	Time between the inhalation anesthesia stop and cooperation to verbal impulses in minutes	Up to 2 hours
Secondary	Delta Oxygen Concentration	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"	up to 2 hours