RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis

Hospital do Coracao

Status: Terminated

Conditions: Pulmonary Fibrosis; Acute Respiratory Failure

Treatments: Device: High Flow Nasal Catheter; Device: Noninvasive positive pressure ventilation (NIPPV)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04253405

IP-HCOR/RENOVATEfibrose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

High Flow Nasal Cannula (HFNC)

Active Comparator group

Description:

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.

Treatment:

Device: High Flow Nasal Catheter

Non-invasive positive pressure ventilation (NIPPV)

Active Comparator group

Description:

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.

Treatment:

Device: Noninvasive positive pressure ventilation (NIPPV)