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

NCT ID: NCT04253405

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2021-08-09

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.

Conditions

Acute Respiratory Failure; Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

High Flow Nasal Catheter

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Noninvasive positive pressure ventilation (NIPPV)

Intervention Type: DEVICE

NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Optiflow; Airvo; trans-nasal insufflation; Nasal High Flow; High Flow Nasal Cannula; BiPAP; Non-invasive ventilation; Non-invasive positive pressure ventilation

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leticia Kawano-Dourado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração

Israel Maia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração

Locations

Hospital UNIMED Vitória

Vitória, Espírito Santo, Brazil

Hospital de Brasilia (HOBRA)

Brasília, Federal District, Brazil

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Instituto de Cardiologia Dante Pazanese

São Paulo, São Paulo, Brazil

Hospital do Coracao

São Paulo, , Brazil

InCor - Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

IP-HCOR/RENOVATEfibrose

Identifier Type: -

Identifier Source: org_study_id