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

Primary Purpose

Acute Respiratory Failure, Pulmonary Fibrosis

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High Flow Nasal Catheter
Noninvasive positive pressure ventilation (NIPPV)
Sponsored by
Hospital do Coracao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Brasilia (HOBRA)
  • Hospital UNIMED Vitória
  • Instituto de Cardiologia Dante Pazanese
  • Hospital Nereu Ramos
  • Hospital do Coracao
  • InCor - Hospital das Clinicas da Faculdade de Medicina da USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High Flow Nasal Cannula (HFNC)

Non-invasive positive pressure ventilation (NIPPV)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2020
Last Updated
August 9, 2021
Sponsor
Hospital do Coracao
Collaborators
Ministry of Health, Brazil, Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04253405
Brief Title
RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis
Acronym
Fibrosis
Official Title
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
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Study impacted by the COVID-19 pandemic: slow recruitment rate budget constrains
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
August 9, 2021 (Actual)
Study Completion Date
August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
Collaborators
Ministry of Health, Brazil, Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula (HFNC)
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-invasive positive pressure ventilation (NIPPV)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Catheter
Other Intervention Name(s)
Optiflow, Airvo, trans-nasal insufflation, Nasal High Flow, High Flow Nasal Cannula
Intervention Description
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
Intervention Name(s)
Noninvasive positive pressure ventilation (NIPPV)
Other Intervention Name(s)
BiPAP, Non-invasive ventilation, Non-invasive positive pressure ventilation
Intervention Description
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.
Primary Outcome Measure Information:
Title
Recruitment feasibility
Description
Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Dyspneia variation (Borg scale)
Description
Borg scale
Time Frame
7 days
Title
Respiratory frequency variation
Description
Respiratory rate
Time Frame
7 days
Title
oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
Description
Oxygen index
Time Frame
7 days
Title
Carbon dioxide arterial partial pressure (PaCO2) variation
Description
CO2 variation
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Comfort visual analog scale variation
Description
Confort scale
Time Frame
7 days
Title
Endotracheal intubation (ETI) rate
Description
Endotracheal intubation
Time Frame
7 days
Title
Mortality
Description
Mortality in 28 days
Time Frame
28 days
Title
Mortality
Description
Mortality in 90 days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leticia Kawano-Dourado, MD
Organizational Affiliation
Hospital do Coração
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Israel Maia, MD
Organizational Affiliation
Hospital do Coração
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Brasilia (HOBRA)
City
Brasília
State/Province
DF
Country
Brazil
Facility Name
Hospital UNIMED Vitória
City
Vitória
State/Province
ES
Country
Brazil
Facility Name
Instituto de Cardiologia Dante Pazanese
City
São Paulo
State/Province
Sao Paulo
Country
Brazil
Facility Name
Hospital Nereu Ramos
City
Florianópolis
State/Province
SC
Country
Brazil
Facility Name
Hospital do Coracao
City
Sao Paulo
Country
Brazil
Facility Name
InCor - Hospital das Clinicas da Faculdade de Medicina da USP
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing plan - under construction
IPD Sharing Time Frame
In 8 months
IPD Sharing Access Criteria
Publication

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

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