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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Fibrosis; Acute Respiratory Failure
• Intervention / Treatment: Device: High Flow Nasal Catheter; Device: Noninvasive positive pressure ventilation (NIPPV)

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital do Coracao
  • Sao Paulo, Brazil
    • INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
  • DF
    • Brasília, DF, Brazil
      • Hospital de Brasilia (HOBRA)
  • ES
    • Vitória, ES, Brazil
      • Hospital UNIMED Vitória
  • SC
    • Florianópolis, SC, Brazil
      • Hospital Nereu Ramos
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil
      • Instituto de Cardiologia Dante Pazanese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Other Names: Optiflow; Airvo; trans-nasal insufflation; Nasal High Flow; High Flow Nasal Cannula
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.	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.; Other Names: BiPAP; Non-invasive ventilation; Non-invasive positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months	18 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort visual analog scale variation	Confort scale	7 days
Endotracheal intubation (ETI) rate	Endotracheal intubation	7 days
Mortality	Mortality in 28 days	28 days
Mortality	Mortality in 90 days	90 days

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Ministry of Health, Brazil; Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Leticia Kawano-Dourado, MD, Hospital do Coracao; Principal Investigator: Israel Maia, MD, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Fibrosis; Respiratory Insufficiency; Pulmonary Fibrosis; Respiratory Distress Syndrome
• Other Study ID Numbers: IP-HCOR/RENOVATEfibrose

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data sharing plan - under construction
• IPD Sharing Time Frame: In 8 months
• IPD Sharing Access Criteria: Publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No