Multicentric Randomized Controlled Pilot Study Comparing High Flow Nasal Cannula Versus NonInvasive Positive Pressure Ventilation in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (RENOVATE Fibrosis)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 6
- 主要终点
- Recruitment feasibility
研究概览
简要总结
A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.
详细描述
RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.
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
- •Sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria A and B bellow.
- •A. Pulmonary fibrosis will be defined by all of the criteria below:
- •presence of Velcro-type crackles on physical examination
- •imaging compatible with pulmonary fibrosis
- •diffuse disease on imaging
- •B. Acute respiratory failure (ARF) will be defined by hypoxemia evidenced by SpO2 <90% or PaO2 <60 mmHg in room air and at least two of the criteria below within the last four weeks:
- •worsening dyspnea
- •worsening breathing effort
- •worsening gas exchange (worsening SpO2 or paO2)
- •worsening respiratory rate, above 25 irpm
排除标准
- •Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
- •Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index <2L / min / m2 in catheterization of right chambers;
- •Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
- •Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
- •Presence of delirium or non-cooperation at the time of randomization;
- •Anatomical facial abnormalities;
- •Incoercible vomiting or hypersecretion of the airways;
- •Use of continuous VNIPP or HFNC for more than 8h before randomization;
- •pregnancy;
- •Refusal to participate.
研究组 & 干预措施
High Flow Nasal Cannula (HFNC)
The HFNC (Airvo2 Fisher & Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min.
干预措施: High Flow Nasal Catheter (Device)
Non-invasive positive pressure ventilation (NIPPV)
NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or an invasive mechanical ventilator with NIPPV mode are accepted. The interface should be an oronasal or full face mask.
干预措施: Noninvasive positive pressure ventilation (NIPPV) (Device)
结局指标
主要结局
Recruitment feasibility
时间窗: 18 months
Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
次要结局
- Carbon dioxide arterial partial pressure (PaCO2) variation(7 days)
- Dyspneia variation (Borg scale)(7 days)
- Respiratory frequency variation(7 days)
- oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation(7 days)