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临床试验/NCT05644340
NCT05644340已完成不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Total amount of sevoflurane consumed

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Emergency surgery
  • •Patients who are contraindicated for inhalation anesthesia

研究组 & 干预措施

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.

干预措施: Speed 8 (Fast balancing gas flow) (Procedure)

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.

干预措施: Speed 4 (Medium speed balancing gas flow) (Procedure)

结局指标

主要结局

Total amount of sevoflurane consumed

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Savran Karadeniz

Associate Professor

Istanbul University

研究点 (1)

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