RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis
- Conditions
- Acute Respiratory FailurePulmonary Fibrosis
- Interventions
- Device: High Flow Nasal CatheterDevice: Noninvasive positive pressure ventilation (NIPPV)
- Registration Number
- NCT04253405
- Lead Sponsor
- Hospital do Coracao
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Flow Nasal Cannula (HFNC) High Flow Nasal Catheter 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. Non-invasive positive pressure ventilation (NIPPV) Noninvasive 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.
- Primary Outcome Measures
Name Time Method Recruitment feasibility 18 months Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
- Secondary Outcome Measures
Name Time Method oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation 7 days Oxygen index
Dyspneia variation (Borg scale) 7 days Borg scale
Respiratory frequency variation 7 days Respiratory rate
Carbon dioxide arterial partial pressure (PaCO2) variation 7 days CO2 variation
Trial Locations
- Locations (6)
Hospital Nereu Ramos
🇧🇷Florianópolis, SC, Brazil
Hospital de Brasilia (HOBRA)
🇧🇷Brasília, DF, Brazil
Hospital UNIMED Vitória
🇧🇷Vitória, ES, Brazil
Instituto de Cardiologia Dante Pazanese
🇧🇷São Paulo, Sao Paulo, Brazil
InCor - Hospital das Clinicas da Faculdade de Medicina da USP
🇧🇷Sao Paulo, Brazil
Hospital do Coracao
🇧🇷Sao Paulo, Brazil