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

Overview

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 Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 10, 2022

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.

Interventions

  • Device: High Flow Nasal Catheter
    • HFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees. Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2
  • Device: Noninvasive positive pressure ventilation (NIPPV)
    • NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment feasibility
    • Time Frame: 18 months
    • Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months

Secondary Measures

  • Dyspneia variation (Borg scale)
    • Time Frame: 7 days
    • Borg scale
  • Respiratory frequency variation
    • Time Frame: 7 days
    • Respiratory rate
  • oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
    • Time Frame: 7 days
    • Oxygen index
  • Carbon dioxide arterial partial pressure (PaCO2) variation
    • Time Frame: 7 days
    • CO2 variation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital do Coracao
  • Collaborator
    • Ministry of Health, Brazil
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Leticia Kawano-Dourado, MD, Principal Investigator, Hospital do Coração
    • Israel Maia, MD, Principal Investigator, Hospital do Coração
  • Overall Contact(s)
    • Leticia Kawano Dourado, MD, +55 11 3053-6611, ldourado@hcor.com.br

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