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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.
Hospital UNIMED Vitória
Vitória, Espírito Santo, Brazil
Hospital de Brasilia (HOBRA)
Brasília, Federal District, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Instituto de Cardiologia Dante Pazanese
São Paulo, São Paulo, Brazil
Recruitment feasibility
Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
Time frame: 18 months
Dyspneia variation (Borg scale)
Borg scale
Time frame: 7 days
Respiratory frequency variation
Respiratory rate
Time frame: 7 days
oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
Oxygen index
Time frame: 7 days
Carbon dioxide arterial partial pressure (PaCO2) variation
CO2 variation
Time frame: 7 days
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Hospital do Coracao
São Paulo, Brazil
InCor - Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, Brazil