NCT01572337已完成4 期
Reducing the Need for Intensive Care Unit in Hospitalized Patients With Early Respiratory Failure Using the Non-invasive Ventilation Technique. A Multicentre Randomized Study.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 14
- 主要终点
- Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure
研究概览
简要总结
A large multicentre, randomized, controlled trial to demonstrate that non invasive ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to the best available treatment usually performed in the non-ICU wards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age >= 18 years
- •Admission in a non-intensive-care department
- •Radiological evidence of new pulmonary consolidation or atelectasis
- •Peripheral Oxygen saturation less than 92% while breathing room air or PaO2/FiO2 ratio less than 300 at blood gas analysis
- •Decompensated hypercapnia (pCO2 > 45 mmHg and pH < 7.35)
- •Clinical signs of respiratory distress (dyspnoea, utilization of accessory respiratory muscles, paradox movements of thoraco-abdominal wall) in air.
排除标准
- •Respiratory failure due to chronic obstructive pulmonary disease exacerbation, defined as PaCO2 > 45 and pH < 7.35 (in these patients NIV is considered to be the standard/first line treatment and we do not want to deny these patients the opportunity to receive this treatment because of randomization)
- •Severe, hypercapnic ARF defined as PaCO2 > 45 and pH < 7.30
- •Severe, hypoxic ARF defined as PaO2/FiO2 < 200
- •Need for immediate mechanical ventilation or ICU as judged by the ICU physician in charge
- •Extremely poor short term prognosis (imminent death with decision for palliative treatment only)
- •Invasive or non-invasive mechanical ventilation during the same hospitalization due to respiratory failure.
- •Clear contraindication to NIV treatment: respiratory arrest, failure to correct positioning of a face mask, hemodynamic instability due to hypotensive shock, ongoing myocardial ischemia, arrhythmia, massive bleeding from upper gastrointestinal tract, patient uncooperative and upset, inability to protect airways, alterations of deglutition, inability to clear secretion also with external aspiration, multiple organs dysfunction, recent surgery of airways or upper gastrointestinal tract, not-drained pneumothorax, bowel obstruction, active vomit.
研究组 & 干预措施
Best available treatment
Other
干预措施: Standard care (Other)
NIV
Experimental
Non-invasive ventilation
干预措施: Non-invasive ventilation (Procedure)
结局指标
主要结局
Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure
时间窗: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
次要结局
未报告次要终点
研究者
Giovanni Landoni
Head of Research, Department of Anesthesiology and Intensive Care
Università Vita-Salute San Raffaele
研究点 (14)
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