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临床试验/NCT02653365
NCT02653365已完成不适用

Predictors of Non-invasive Ventilation Failure in Patients With Acute Cardiogenic Pulmonary Edema

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
1
主要终点
Heart rate

研究概览

简要总结

The aims of our study was to identify early predictors of non-invasive ventilation failure, so as to alert clinicians early that endotracheal intubation and mechanical ventilation might be appropriate.

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

  • Presence of ACPE diagnosed based on SpO2 below 90% with >5 L/ min oxygen via reservoir face mask
  • Acute respiratory distress as evidenced by severe dyspnea
  • Breathing frequency of >30 breaths/min, and use of accessory respiratory muscles or paradoxical abdominal motion in association with tachycardia
  • Cardiac gallops, bilateral rales, and typical findings of congestion on chest radiography, without a history suggesting pulmonary aspiration or evidence of pneumonia.

排除标准

  • Patients were excluded from the study if they were intubated before ICU admission, or required immediate intubation without prior NIV, or presented a respiratory or cardiac arrest
  • Severe hemodynamic instability (systolic arterial pressure <70 mmHg despite adequate fluid repletion and use of vasoactive agents) or life-threatening ventricular arrhythmias.
  • Patients were also excluded if they were unresponsive, agitated, and unable to cooperate; or if they had any condition that precluded application of a face mask including upper airway obstruction
  • Recent oral or facial trauma or surgery
  • Recent gastric or esophageal surgery
  • Inability to clear respiratory secretions or high risk for aspiration.
  • In addition, patients were excluded if they had a "do not intubate" order or refused research authorization.

结局指标

主要结局

Heart rate

时间窗: From study entry to death or ICU discharge, up to 3 years.

Breath frequency

时间窗: From study entry to death or ICU discharge, up to 3 years.

Fluid balance within 24 hours after presence of acute cardiogenic pulmonary edema.

时间窗: From study entry to death or ICU discharge, up to 3 years.

Age

时间窗: From study entry to death or intensive care unit (ICU) discharge, up to 3 years.

Blood pressure

时间窗: From study entry to death or ICU discharge, up to 3 years.

Arterial blood gas

时间窗: From study entry to death or ICU discharge, up to 3 years.

New York Heart Association classification

时间窗: From study entry to death or ICU discharge, up to 3 years.

The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Killip classification

时间窗: From study entry to death or ICU discharge, up to 3 years.

The Killip classification is a system used in individuals with an acute myocardial infarction, in order to risk stratify them. Patients were ranked by Killip class in the following way: Killip class I includes individuals with no clinical signs of heart failure. Killip class II includes individuals with rales or crackles in the lungs, an S3, and elevated jugular venous pressure. Killip class III describes individuals with frank acute pulmonary edema. Killip class IV describes individuals in cardiogenic shock or hypotension (measured as systolic blood pressure lower than 90 mmHg), and evidence of peripheral vasoconstriction (oliguria, cyanosis or sweating).

Left ventricular ejection fraction

时间窗: From study entry to death or ICU discharge, up to 3 years.

B-type natriuretic peptide

时间窗: From study entry to death or ICU discharge, up to 3 years.

次要结局

未报告次要终点

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zujin Luo

Attending physician

Beijing Chao Yang Hospital

研究点 (1)

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