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

NCT04253405 | Terminated

• 1 other identifier: IP-HCOR/RENOVATEfibrose
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Respiratory Failure; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Recruitment feasibility

  Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months

  18 months

Secondary Outcomes (4)

• Dyspneia variation (Borg scale)

  7 days

• Respiratory frequency variation

  7 days

• oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation

  7 days

• Carbon dioxide arterial partial pressure (PaCO2) variation

  7 days

Other Outcomes (4)

• Comfort visual analog scale variation

  7 days

• Endotracheal intubation (ETI) rate

  7 days

• Mortality

  28 days

Study Arms (2)

High Flow Nasal Cannula (HFNC)

ACTIVE COMPARATOR

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

Non-invasive positive pressure ventilation (NIPPV)

ACTIVE COMPARATOR

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)

Interventions

High Flow Nasal Catheter 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

Also known as: Optiflow, Airvo, trans-nasal insufflation, Nasal High Flow, High Flow Nasal Cannula

High Flow Nasal Cannula (HFNC)

Noninvasive positive pressure ventilation (NIPPV) DEVICE

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

Also known as: BiPAP, Non-invasive ventilation, Non-invasive positive pressure ventilation

Non-invasive positive pressure ventilation (NIPPV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ministry of Health, Brazil: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (6)

Hospital UNIMED Vitória

Vitória, Espírito Santo, Brazil

Location

Hospital de Brasilia (HOBRA)

Brasília, Federal District, Brazil

Location

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

Instituto de Cardiologia Dante Pazanese

São Paulo, São Paulo, Brazil

Location

Hospital do Coracao

São Paulo, Brazil

Location

InCor - Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, Brazil

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Leticia Kawano-Dourado, MD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

• Israel Maia, MD

  Hospital do Coração

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized controlled study

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: December 10, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: In 8 months
• Access Criteria: Publication

Locations

BR (6)