High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in NT-proBNP from baseline to 72 hours
研究概览
简要总结
The primary objective of this pilot trial is to determine whether inpatients presenting to the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.
详细描述
Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>40 years of age presenting to the ED with AHF
- •objective finding of HF (BNP >400 pg/ml or Chest X-Ray with pulmonary congestion)
- •plan to admit with primary diagnosis as HF
- •must be able to be randomized within 16 hours of presenting to the ED
- •provided written informed consent
排除标准
- •on home oxygen
- •known prior hypercapnic failure (PaCO2 >50 mmHg)
- •primary pulmonary hypertension,
- •patients who require urgent positive pressure ventilation or intubation
- •patients on >10 L/min oxygen
研究组 & 干预措施
High SpO2
In the high SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range ≥96%
干预措施: High SpO2 (Other)
Low SpO2
In the low SpO2 set-point arm, patients will have a nasal cannula placed and will be manually titrated to SpO2 range 90-92%
干预措施: Low SpO2 (Other)
结局指标
主要结局
Change in NT-proBNP from baseline to 72 hours
时间窗: 72 hours
次要结局
- Hochberg endpoint (combination of NT-proBNP and PGA)(72 hours)
- Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)(72 hours)
- Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours(72 hours)
- Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours(72 hours)
- 30-day clinical events(30 days)
- Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization(30 days)
- Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours(72 hours)
- Number of worsening heart failure (WHF) events(7 days)