Feasibility and Safety Properties of Metabolic Flow Anesthesia Driven by Automated Gas Control in Pediatric Patients
NCT ID: NCT05644340
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
130 participants
INTERVENTIONAL
2022-12-16
2023-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Minimal Flow Application in One Lung Ventilation
NCT04376307
The Effect of Minimal Flow Anesthesia on Oxidative and Neuroendocrine Stress Response
NCT06611449
Is Low Flow Anaesthesia Feasible?
NCT06389669
Perfusion Index in Pediatric Low-Flow Anesthesia
NCT06967675
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels and Postoperative Patient Outcomes in Pediatric Cardiovascular Surgery
NCT06097806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Automated Gas Flow Group using speed 8 to reach targeted end-tidal sevoflurane concentration
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.
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.
Automated Gas Flow Group using speed 4 to reach targeted sevoflurane concentration
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective or Semielective surgeries
* Patients suitable for inhalation anesthesia
Exclusion Criteria
* Patients who are contraindicated for inhalation anesthesia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Meltem Savran Karadeniz
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istanbul University Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/154
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.