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临床试验/NCT01237886
NCT01237886已完成不适用

Weaning And Variability Evaluation

Ottawa Hospital Research Institute14 个研究点 分布在 2 个国家目标入组 660 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
660
试验地点
14
主要终点
Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms

研究概览

简要总结

Knowing when to liberate patients from mechanical ventilation (i.e. removal of breathing or endotracheal tube or extubation) is critically important, as both prolonged ventilation and failed extubation are both associated with harm and risk of death. Our objective is to improve the safety of extubation by harnessing hidden information contained in the patterns of variation of heart and respiratory rate measured over intervals-in-time. Currently, to assess a patient's ability to be extubated, a spontaneous breathing trial (SBT) is routinely performed, where the level of ventilator support is reduced, and their response is observed in order to help predict if they will tolerate extubation (i.e. complete removal of ventilator support). Given that health is associated with a high degree of variation of physiologic parameters (e.g. heart and respiratory rate), and illness & stress are associated with a loss of variability, the investigators aim to uncover the loss of variation as a measure of stress during SBT's. The investigators hypothesize that maintaining stable heart rate and respiratory rate variability (HRV and RRV) throughout the SBT will predict subsequent successful extubation, and conversely, a reduction in either HRV or RRV manifest during a SBT predicts extubation failure. A pilot study has demonstrated feasibility, and compelling preliminary results. A website, centralized data storage and analysis, and a trans-disciplinary team of scientists are in place to definitively test this novel technology. Determination of when to extubate critically ill patients remains a high-stakes clinical challenge; and improved prediction of extubation failure has potential to save lives and reduce costs in critically ill patients.

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

  • Invasive mechanical ventilation for >48 hours,
  • patient is ready for SBTs for assessment for extubation,
  • has a normal sinus rhythm at time of SBT (no pacemaker),
  • is tolerating pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O),
  • hemodynamically stable (low or no vasopressors), stable neurological status (no deterioration in GCS during prior 24 hours & ICP < 20),
  • intact airway reflexes (cough & gag).

排除标准

  • Order not to re-intubate,
  • anticipated withdrawal of life support,
  • known or suspected severe weakness (myopathy, neuropathy or quadriplegia),
  • tracheostomy,
  • and prior extubation during ICU stay.

结局指标

主要结局

Continuous heart rate (electrocardiogram) & respiratory rate (CO2 capnography) waveforms

时间窗: at time of spontaneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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