Pronation in Spontaneously Breathing Patients With Acute Respiratory Failure Deu to Covid-19: Multicenter, Randomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- number of day free of ventilatory support
研究概览
简要总结
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion
详细描述
Observational studies have shown that prone position (PP) in spontaneously breathing patients, may improve oxygenation in individuals with Acute Respiratory Failure (ARF), due to Covid-19 infection.
These studies were mainly physiological and reported in a subset of patients a poor tolerance. Indeed most of the beneficial effects on gas exchage disappeared in around 40% of tyhe patients, once the patients regained the supine position.
None so far have evaluated the clinical efficacy of this approach on the patients' outcomes and in a randomised control fashion.
This holds particularly true in those patients affected by mild de-novo ARF (PaO2/FiO2 ratio within the range of 200-300), where any form of respiratory support like Continuous Positive Airways Pressure (CPAP), High Flow Nasal Cannula (HFNC) or Noninvasive ventilation (NIV), may be not yet indicated, especially if the patients are admitted to a regular ward as for the case of Covid-19 pandemics, due to the lack of "protected" beds.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed COVID-19 infection using PCR
- •Acute Respiratory Failure ( 200 <PaO2/FiO2 <300) and respiratory rate < 30 atti/min
- •O2 therapy initiated <72 hrs
- •informed consent
排除标准
- •Glasgow Coma Scale (GCS) < 13
- •pH< 7,45, PaCO2 >45 mmHg
- •need for HFNC, CPAP, NIV or intubation
- •hemodynamic instability increase of 80-90 mmHg or reduction of 30-40 mmHg in systolic blood pressure
- •severe arrythmia of myocardial infarction
- •need for sedation
- •intolerance to PP
- •pregnancy
- •Body mass index (BMI) > 35 kg/m2.
结局指标
主要结局
number of day free of ventilatory support
时间窗: 1 month
number of days in which the patient will not need (according to standardized criterai) any for of these ventilatory support like NIV,CPAP, HFNC or intubation
次要结局
- dyspnea(1 month)
- comfort during PP(1 month)
- changes in respiratory pattern(1 month)
- daily changes in the ratio SaO2/FiO2(1 month)
研究者
dr. Stefano Nava
professor and chief of respiratory and critical care unit
IRCCS Azienda Ospedaliero-Universitaria di Bologna