Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,078
- 试验地点
- 35
- 主要终点
- Intubation within 28 days of randomization
研究概览
简要总结
Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome.
Among invasively mechanically ventilated patients with ARDS and presenting a PaO2/FiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.
Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.
Coordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to an intensive care unit or intermediate care unit
- •Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
- •And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
- •PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
- •Person affiliated to a French social security system or equivalent
- •Informed consent.
排除标准
- •Positive SARS-COV2 test within the last 30 days
- •Indication for immediate intubation
- •Patients for whom a "do not intubate" decision has been made
- •Chest trauma or other contraindication to prone position
- •Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.
- •Pregnant or breastfeeding woman
- •Subjects who are under legal protection measure
- •More than 8h awake prone positioning prior to inclusion
- •More than 48h since intensive care unit or intermediate care unit admission.
研究组 & 干预措施
Prone position group
patients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions.
干预措施: Prone position (Other)
Control group
Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning.
结局指标
主要结局
Intubation within 28 days of randomization
时间窗: From randomization to day 28
Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events.
次要结局
- Evolution of patient's quality of life(At 5 years)
- Mortality(From randomization to day 90)
- Evolution of patient's quality of life(At 90 days)
- Patient comfort before the first prone session, using a visual analogue scale.(From randomization to 6 hours)
- Patient comfort during the first prone session, using a visual analogue scale.(From randomization to day 1)
- Patient comfort after the first prone session, using a visual analogue scale.(From randomization to day 1)
- Time to intensive care unit discharge and time to hospital discharge (up to day 28).(From randomization to day 28)
- Mortality(From randomization to day 28 or intensive care unit and hospital discharge)
- Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group.(From randomization to 6 hours)
- Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group.(From randomization to day 1)
- Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group.(From randomization to day 1)
- Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale.(From day 1 to day 3)
- Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3.(From day 1 to day 3)
- Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).(From randomization to day 28 or intensive care unit discharge whichever occurs first)
- Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first).(From randomization to day 28 or intensive care unit discharge whichever occurs first)
- Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups(From randomization to 24 hours post randomization)
- Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first).(From randomization to day 28 or intensive care unit discharge whichever occurs first).)