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临床试验/NCT02687802
NCT02687802已完成不适用

Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2016年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
asynchrony index

研究概览

简要总结

The objective of the study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including patients under invasive mechanical ventilation. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously and quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge.

详细描述

Patient-ventilator asynchrony is common in patients under invasive mechanical ventilation, present between 10 and 80% of all respiratory cycles, and is associated with adverse clinical outcomes, such as delay in the weaning process, increased complications of mechanical ventilation, with possible impact on survival. The objective of this study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including all patients under invasive mechanical ventilation admitted at Respiratory ICU at Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo (USP), during the study period. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously. The ventilator waveforms will be captured directly from ventilator and processed by dedicated software, without direct contact with patients. Later, ventilator waveforms will be analyzed to quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge, and the investigators will record duration of mechanical ventilation, the use of non-invasive ventilation post-extubation, reintubation, tracheostomy, ICU and hospital length of stay and survival. With this project, the investigators will estimate the incidence and magnitude of patient-ventilator asynchrony and its association with clinical outcomes

研究设计

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

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

  • Recent mechanical ventilation (less than 72 hours)
  • Expectation of mechanical ventilation for more than 24 hours
  • Age ≥ 18 years old

排除标准

  • High flow Bronchopleural fistula
  • Thoracic or abdominal deformities that could compromise the accuracy of respiratory mechanics measurement
  • Impossibility to measure respiratory mechanics
  • Tracheostomy

结局指标

主要结局

asynchrony index

时间窗: from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days

asynchrony index will be calculated as the number of major asynchrony events divided by total number of respiratory cycles

次要结局

  • ventilation free-days(28 days)
  • Clinical signs of patient-ventilator asynchrony(daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days)
  • tracheostomy rate(up to 90 days)
  • Survival rate(at 28 and 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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