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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253405
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
Ministry of Health, Brazil
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within 18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Pulmonary Fibrosis Device: High Flow Nasal Catheter Device: Noninvasive positive pressure ventilation (NIPPV) Not Applicable

Detailed Description:

RENOVATE Fibrosis is a randomized controlled trial (RCT) testing the feasibility of recruiting pulmonary fibrosis patients in acute respiratory failure (ARF) while also investigating, in a preliminary way, important efficacy and safety outcome´s effect size.

RENOVATE Fibrosis will recruit centrally adjudicated pulmonary fibrosis cases in acute respiratory distress to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables, comfort, ETI rate, mortality in 28 and 90 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : April 30, 2022


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




Primary Outcome Measures :
  1. Recruitment feasibility [ Time Frame: 18 months ]
    Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months


Secondary Outcome Measures :
  1. Dyspneia variation (Borg scale) [ Time Frame: 7 days ]
    Borg scale

  2. Respiratory frequency variation [ Time Frame: 7 days ]
    Respiratory rate

  3. oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation [ Time Frame: 7 days ]
    Oxygen index

  4. Carbon dioxide arterial partial pressure (PaCO2) variation [ Time Frame: 7 days ]
    CO2 variation


Other Outcome Measures:
  1. Comfort visual analog scale variation [ Time Frame: 7 days ]
    Confort scale

  2. Endotracheal intubation (ETI) rate [ Time Frame: 7 days ]
    Endotracheal intubation

  3. Mortality [ Time Frame: 28 days ]
    Mortality in 28 days

  4. Mortality [ Time Frame: 90 days ]
    Mortality in 90 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Sequential adult patients 18 years of age or older admitted to the ICU or emergency department 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
  • diffuse pulmonary fibrosis on imaging confirmed by real-time central adjudication

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 IRPA 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253405


Contacts
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Contact: Leticia Kawano Dourado, MD +55 11 3053-6611 ext 8209 ldourado@hcor.com.br
Contact: Karina Negrelli, Asst +55 11 3053-6611 ext 8201 knegrelli@hcor.com.br

Sponsors and Collaborators
Hospital do Coracao
Ministry of Health, Brazil
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Leticia Kawano-Dourado, MD Hospital do Coração
Principal Investigator: Israel Maia, MD Hospital do Coração
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT04253405    
Other Study ID Numbers: IP-HCOR/RENOVATEfibrose
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing plan - under construction
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: In 8 months
Access Criteria: Publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Fibrosis
Respiratory Distress Syndrome, Adult
Fibrosis
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases