Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The rate of intubation among participant
研究概览
简要总结
High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).
To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.
详细描述
- Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
- •The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
- •Exclusion criteria:
- •Patients requiring emergency intubation,
- •Recent esophageal, facial, or cranial trauma or surgery,
- •Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less),
- •Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
- •Tracheotomy or other upper airway disorders,
- •Active upper gastrointestinal bleeding, and
- •Inability to clear respiratory secretions .
排除标准
- 未提供
结局指标
主要结局
The rate of intubation among participant
时间窗: within 72 hours after admission
The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 \< 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency \> 40/min)
次要结局
- Improvement of respiratory exchanges compared to baseline(hospital admission until the achievement of clinical stability (72 hours))
- Dyspnea(hospital admission until the achievement of clinical stability (72 hours))
- Mortality rate(at 28 days)
研究者
Doaa Magdy Eid
associate proffessour
Assiut University