Restrictive Versus Liberal Oxygenation Targets in Patients With Acute Heart Failure and Pulmonary Congestion - a Randomized Clinical Pilot-trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Pulmonary parenchymal fluid content after 24 hours
研究概览
简要总结
This investigator-initiated, prospective, randomized, blinded, multi-center, controlled trial will investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure with pulmonary congestion.
Patients will be randomized 1:1 in the emergency department to either liberal or restrictive oxygenation after providing informed written consent.
- Liberal oxygenation group = SpO2 target of 96%.
- Restrictive oxygenation group = SpO2 target of 90%.
The allocation will be concealed through the use of an oxygen-delivery robot, termed O2MATIC. The study will include 122 patients.
详细描述
Background:
One million hospitalizations occur each year with a primary diagnosis of acute heart failure in the USA, with comparable numbers in Europe. Most patients with acute heart failure are treated with supplemental oxygen during hospitalization and guidelines recommend initiation of oxygen therapy if SpO2 <90% (class I, level C). However, no clinical trials of oxygen targets in humans with acute heart failure investigating clinically relevant endpoints have been performed.
Primary objective:
To investigate the effect of a restrictive vs. liberal oxygenation-strategy in patients hospitalized with acute heart failure.
Hypothesis:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Oxygen-delivery will be given through a robot, which adjusts oxygen-flow towards a given oxygen-saturation target. The robots monitor will be turned of during the intervention and will only alarm in case of clinically relevant hypoxemia.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Acute (within minutes to days) onset or worsening of subjective dyspnea
- •Oxygen saturation <92% (on arterial blood gas) or need of oxygen
- •At least one of the following clinical or radiological signs of congestion:
- •1. Pulmonary rales
- •Chest X-ray or CT with pulmonary congestion
- •Lung ultrasound with multiple B-lines
排除标准
- •More than 4 hours from hospital admission to randomization
- •Suspected infection or sepsis
- •Known severe pulmonary disease
- •Systolic blood pressure <90 mmHg
研究组 & 干预措施
Liberal oxygenation group
SpO2 target of 96%
干预措施: Oxygen (Drug)
Restrictive oxygenation group
SpO2 target of 90%.
干预措施: Oxygen (Drug)
结局指标
主要结局
Pulmonary parenchymal fluid content after 24 hours
时间窗: 24 hours
Pulmonary parenchymal fluid content after 24 hours preceded by 10 minutes without oxygen-supplementation assessed noninvasively by the remote dielectric sensing (ReDS) device (Sensible Medical, Netanya, Israel)
次要结局
- Time to freedom from oxygen-supplementation(48 hours)
- All-cause mortality(30 days)
- Days alive out-of-hospital(30 days)
- Tricuspid annular plane systolic excursion(24 hours)
- 4) Change from baseline in log-transformed biomarkers N-Terminal Pro-Brain Natriuretic Peptide to 24 hours from admission.(24 hours)
- 5) Arterial blood gas concentration after 24 hours preceded by 10 minutes without oxygen-supplementation.(24 hours)
- Global longitudinal strain of the right ventricle(24 hours)
研究者
Johannes Grand
Principal Investigator
Copenhagen University Hospital, Hvidovre