RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (Fibrosis)
Acute Respiratory Failure, Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria: 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital de Brasilia (HOBRA)
- Hospital UNIMED Vitória
- Instituto de Cardiologia Dante Pazanese
- Hospital Nereu Ramos
- Hospital do Coracao
- InCor - Hospital das Clinicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
High Flow Nasal Cannula (HFNC)
Non-invasive positive pressure ventilation (NIPPV)
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.
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.