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临床试验/NCT04851314
NCT04851314已完成不适用

Low-flow Anesthesia: Cost-effectiveness of the FLOW-i Anesthesia Machine, a Comparison to Established Anesthesia Delivery Unit

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年2月14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
110
试验地点
1
主要终点
Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia

研究概览

简要总结

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the a low-flow anesthesia machine to a traditional anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

详细描述

The study member will screen for potential subjects using the UCIMC surgical schedule. If a subject is deemed ineligible based on the inclusion and exclusion criteria after reviewing the medical history, his/her record will be discarded. No records will be retained from ineligible subjects. After discussing with the patient's surgeon, study team member will initiate the informed consent process by approaching each eligible subject to explain the study and what it entails. The Lead Researcher will address all questions and concerns from the subject before asking the subject to sign the research consent form.

The GE anesthesia machines currently owned by the operating room will be used to serve as the comparator to the Flow-i machine. The high volume anesthesia machines do not use a low volume system. Subjects will be randomized by recruitment day. On a given recruitment day, all consented subjects will receive anesthesia from one of two groups:

(1) MAQUET FLOW-i device (2) GE anesthetic device

Time points for both groups include:

T0: Time of intubation, when volatile anesthetic are typically first delivered to the patient. We will use 15L/min fresh gas flow, while dictating tidal volumes of 6-8 mL/kg ideal body weight and a PEEP of 6 centimeters of water (cm H2O) in accordance with current best practices.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-65 years
  • •Undergo surgery under general anesthesia in UCI Medical Center
  • •Agree to sign the consent and HIPAA forms
  • •Subjects who are able to receive sevoflurane

排除标准

  • •Subjects under the age of 18
  • •Chronic Obstructive Pulmonary Disease (COPD)
  • •Body Mass Index (BMI) > 30
  • •Pregnant females
  • •Procedures less than 2 hours
  • •Those with known sensitivity to sevoflurane or other halogenated agents; those with known or suspected susceptibility to malignant hyperthermia
  • •Severe Cardiovascular Disease: Left Ventricular Ejection Fraction (LVEF) < 30%

研究组 & 干预措施

ICU certified ventilator

Active Comparator

Participants assigned to receive ventilation with the ICU certified ventilator

干预措施: ICU certified ventilator (Device)

Non-ICU certified ventilator

Active Comparator

Participants assigned to receive ventilation with the Non-ICU certified ventilator

干预措施: Non-ICU certified ventilator (Device)

结局指标

主要结局

Primary Study Variable: Amount of Gas Vaporized Anesthetic Per Minute Anesthesia

时间窗: Intraoperative (minimum of 2 hours of anesthesia)

The purpose of this study is to test whether or not the use of a low volume ventilator in an anesthesia machine reduces anesthetic costs significantly as compared to other high volume machines. The study will compare the FLOW-i anesthesia machine to a GE anesthesia machine during routine elective general surgery in patients with ASA ratings of 1-2 under general anesthesia receiving standard care.

次要结局

  • Time to Reach Aldrete > 8(Up to 24 hours)
  • Time to Extubation From Weaning(Intraoperative (minimum of 2 hours of anesthesia))

研究者

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

Robert Ryan Field

HS/Assistant Clinical Professor; Neuroanesthesiology Clinical Director

University of California, Irvine

研究点 (1)

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