RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (Fibrosis)
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|ClinicalTrials.gov Identifier: NCT04253405|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure Pulmonary Fibrosis||Device: High Flow Nasal Catheter Device: Noninvasive positive pressure ventilation (NIPPV)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomized controlled study|
|Masking:||None (Open Label)|
|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|
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
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.
- Recruitment feasibility [ Time Frame: 18 months ]Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
- Dyspneia variation (Borg scale) [ Time Frame: 7 days ]Borg scale
- Respiratory frequency variation [ Time Frame: 7 days ]Respiratory rate
- oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation [ Time Frame: 7 days ]Oxygen index
- Carbon dioxide arterial partial pressure (PaCO2) variation [ Time Frame: 7 days ]CO2 variation
- Comfort visual analog scale variation [ Time Frame: 7 days ]Confort scale
- Endotracheal intubation (ETI) rate [ Time Frame: 7 days ]Endotracheal intubation
- Mortality [ Time Frame: 28 days ]Mortality in 28 days
- Mortality [ Time Frame: 90 days ]Mortality in 90 days
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
|Contact: Leticia Kawano Dourado, MD||+55 11 3053-6611 ext firstname.lastname@example.org|
|Contact: Karina Negrelli, Asst||+55 11 3053-6611 ext email@example.com|
|Principal Investigator:||Leticia Kawano-Dourado, MD||Hospital do Coração|
|Principal Investigator:||Israel Maia, MD||Hospital do Coração|