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临床试验/NCT02723565
NCT02723565已完成不适用

Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation

University Health Network, Toronto6 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年4月1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
7
试验地点
6
主要终点
Sensitivity and specificity for diagnosis of physiological mechanisms causing weaning failure

研究概览

简要总结

This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of spontaneous breathing to determine the physiological mechanism of weaning failure.

详细描述

The transition to unassisted breathing after invasive ventilation often proves challenging, with over 40% of patients failing their first attempt of unassisted breathing. Persistent ventilator dependence predisposes patients to nosocomial complications and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. Many patients who are dependent on the ventilator also show a striking loss of pump capacity due to diaphragm dysfunction. Though each of these mechanisms respond to specific interventions, it is often difficult for physicians to discern which mechanisms are at play at the bedside. Bedside ultrasound is a potentially useful means of evaluating cardiac, pulmonary and diaphragm function during weaning failure. It is readily available, highly feasible and already widely employed in clinical practice. As yet, no study has evaluated the accuracy and feasibility of combining echocardiography with lung and diaphragm ultrasound to comprehensively evaluate the physiological mechanisms of weaning failure. The objectives of this study are to establish the utility of a rapid thoracic ultrasound exam to diagnose mechanisms of ventilation liberation failure and to assess the relationship between cardiothoracic variability during spontaneous breathing and different physiological mechanism of weaning failure.

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

  • patients over 18 years of age receiving invasive mechanical ventilation for at least 24 hours
  • patients who fulfill standard criteria for readiness for a trial of spontaneous breathing (no or minimal sedation, patient awake and interactive; minimal vasopressor/inotrope requirements (Norepinephrine < or = 0.1, Dopamine < 10, Vasopressin/Epinephrine off); fraction of inspired oxygen < or = 50%; spontaneous inspiratory efforts as indicated by patient-triggered breaths; positive end-expiratory pressure < or = 10 cm H20)
  • patients who fail a trial of spontaneous breathing (transient reduction of ventilator support for any duration up to 2 hours as per local ICU practice - typically PS 5 with PEEP 5 OR CPAP 5 OR T-piece)

排除标准

  • patients with a coagulopathy (INR > 2.5, platelet count < 30x10^6/L) or previously diagnosed bleeding diathesis or are receiving anticoagulant drugs at therapeutic doses (ie. excluding venous thromboembolic prophylaxis)
  • patients with a contraindication to nasogastric tube insertion (esophageal varices, upper GI tract surgery, facial trauma, etc.)
  • patients receiving extra-corporeal life support

结局指标

主要结局

Sensitivity and specificity for diagnosis of physiological mechanisms causing weaning failure

时间窗: Physiological measurements for diagnostic classification measured simultaneously with ultrasound measurements

Mechanisms responsible for weaning failure will be diagnosed by field experts using clinical data collected from the chart along with physiological measurements (respiratory mechanics, maximal inspiratory pressure, markers of pulmonary edema including changes in serum total protein and BNP and central venous pressure). The diagnosis derived from a pre-specified ultrasound-based classification system will be compared to the gold standard expert-derived diagnosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Ewan Goligher

Intensivist

University Health Network, Toronto

研究点 (6)

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