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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04253405
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospital do Coracao
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leticia Kawano-Dourado, MDIsrael Maia, MD
Principal Investigator Affiliation	Hospital do CoraçãoHospital do Coração
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Brazil
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Respiratory Failure, Pulmonary Fibrosis

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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

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.

Contact a Trial Team

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