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临床试验/NCT07734350
NCT07734350尚未招募不适用

Cost-effectiveness of Inhaled Sedation Versus Intravenous Propofol in Mechanically Ventilated Critically Ill Patients: a Retrospective ICU Study

Hospital H+ Queretaro0 个研究点目标入组 400 人开始时间: 2026年7月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
主要终点
Total Cost of Care

研究概览

简要总结

The goal of this observational study is to learn whether inhaled sedation is a cost-effective alternative to intravenous propofol in mechanically ventilated critically ill adults admitted to the intensive care unit. The main questions it aims to answer are:

  • Does inhaled sedation reduce the total cost of care compared with intravenous propofol?
  • Does inhaled sedation reduce the duration of mechanical ventilation and ICU length of stay?
  • Are adverse events different between patients receiving inhaled sedation and those receiving intravenous propofol?

Researchers will compare patients who received inhaled sedation with patients who received intravenous propofol to see if inhaled sedation improves clinical outcomes and reduces overall costs.

Participants will:

  • Be identified through review of electronic medical records
  • Be included if they are adults who received mechanical ventilation and were sedated with inhaled sedation or intravenous propofol
  • Contribute data on total costs of care, duration of mechanical ventilation, ICU length of stay, and adverse event

详细描述

Sedation is an essential component of care for critically ill patients receiving invasive mechanical ventilation in the intensive care unit (ICU). It helps improve patient comfort, reduce metabolic demand, and facilitate ventilator synchrony. Intravenous propofol is widely used for this purpose because of its rapid onset and titratability, but it may be associated with adverse effects such as hypotension, hyperlipidemia, and propofol infusion syndrome. Inhaled sedation with volatile anesthetic agents has re-emerged as an alternative approach in ICU patients, with potential advantages including lower drug accumulation, rapid pulmonary elimination, and possibly shorter duration of mechanical ventilation and ICU stay.

This study is a retrospective observational cohort study conducted in the ICU of Hospital H+ Querétaro. It will include adult patients who required at least 24 hours of mechanical ventilation and received either inhaled sedation or continuous intravenous propofol sedation during their ICU stay. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.

The primary objective is to compare the total cost of inhaled sedation versus intravenous propofol in mechanically ventilated critically ill patients. Secondary objectives are to compare duration of mechanical ventilation, ICU length of stay, adverse events, and indirect costs between the two sedation strategies. The primary outcome is total cost of care, while secondary outcomes include days on mechanical ventilation, ICU stay, and adverse events. Additional variables such as age, sex, SOFA score, APACHE II score, and comorbidities will also be collected.

Data will be collected through review of electronic medical records and recorded in a standardized format. Statistical analysis will be performed using STATA. Descriptive statistics will summarize baseline characteristics and outcomes, and inferential analyses will be used to compare groups, with adjustment for relevant covariates when appropriate. The aim of the study is to determine whether inhaled sedation may represent a cost-effective strategy that improves resource use and clinical outcomes in the ICU setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adults aged 18 years or older
  • Admission to the intensive care unit at Hospital H+ Querétaro
  • Invasive mechanical ventilation for at least 24 hours
  • Receipt of inhaled sedation or continuous intravenous propofol sedation during ICU stay

排除标准

  • Extracorporeal membrane oxygenation
  • Severe traumatic brain injury
  • Transfer to another hospital unit
  • Less than 24 hours of mechanical ventilation

研究组 & 干预措施

Inhaled Sedation Cohort

This cohort includes adult critically ill patients admitted to the intensive care unit at Hospital H+ Querétaro who required invasive mechanical ventilation for at least 24 hours and received inhaled sedation as their primary sedation strategy during ICU stay. In the study protocol, inhaled sedation is defined as the use of isoflurane administered through an anesthetic-conserving device. Patients in this cohort will be identified retrospectively through electronic medical record review and will be evaluated for total cost of care, duration of mechanical ventilation, ICU length of stay, adverse events, and relevant clinical covariates including age, sex, SOFA score, APACHE II score, and comorbidities. Patients with extracorporeal membrane oxygenation, severe traumatic brain injury, transfer to another unit, or less than 24 hours of mechanical ventilation will be excluded.

干预措施: Isoflurane (Drug)

结局指标

主要结局

Total Cost of Care

时间窗: Through ICU discharge, an average of 7 days

次要结局

未报告次要终点

研究者

发起方
Hospital H+ Queretaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose J Zaragoza, MD MSc

Principal Investigator

Hospital H+ Queretaro

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