TCTR20210413001尚未招募2 期
asal High Flow Oxygen Versus Non Invasive Positive Pressure Ventilation in Emergency Department Patients With Cardiogenic Pulmonary Edema: A Randomized Non-inferiority Trial
Siriraj Research and Development Fund0 个研究点目标入组 240 人开始时间: 2021年4月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)(—)
- 性别
- All
入选标准
- •1.Adult patients (18 years of age and above) presenting with ACPE diagnosed by the attending ED physician by meeting all of the following criteria
- •-History of acute dyspnea
- •-Bilateral rales on physical examination
- •-At least one of the following signs on the initial chest radiograph: pulmonary venous congestion, cardiomegaly, and interstitial edema
- •2.Significant respiratory distress in need for non-invasive respiratory support measures by meeting all of the following
- •-Respiratory rate (RR) > 24 breaths/min
- •-Pulse oximetry (SpO2) < 92% when breathing at room air or arterial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) < 300 or SpO2/FiO2 < 240
- •-Signs of respiratory distress, e.g., accessory muscle use
排除标准
- •1.Respiratory failure needing immediate endotracheal intubation, defined as RR > 35 breaths/min, SpO2 < 90% despite oxygen supplement at FiO2= 1.0, or abdominal dyssynchrony
- •2.Patients with cardiac or respiratory arrest
- •3.Patients with hemodynamic instability, defined as systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg with signs of poor tissue perfusion
- •4.Patients with altered mental status, defined as a Glasgow Coma Scale (GCS) score < 13
- •5.Agitated or non-cooperative patients
- •6.Patients contraindicated to the use of NIPPV and HFNC, i.e. at risk for aspiration, known or suspected pneumothorax
- •7.Patients with chronic kidney disease stage V or end-stage renal disease
- •8.Patients with ST-segment elevation myocardial infarction
- •9.Patients with do-not-intubate order
- •10.Patients with long-term non-invasive or invasive respiratory support
- •11.Patients with a tracheostomy tube
- •12.Pregnant patients
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