NCT04253405.
Study name | Multicentric randomized controlled pilot study comparing high‐flow nasal cannula versus non‐invasive positive pressure ventilation in acute respiratory failure in patients with pulmonary fibrosis (RENOVATE Fibrosis) |
Methods | RCT, parallel‐group design. Multicentre study |
Participants | Estimated number of participants: 50 Setting: ICU or ED, Brazil Inclusion criteria: age ≥ 18; admitted to ICU or ED with pulmonary fibrosis and AHRF Exclusion criteria: pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumour form of fibrosis; significant pulmonary arterial hypertension; pneumothorax or extensive pleural effusion; cardiogenic pulmonary congestion; delirium or non‐co‐operation at the time of randomization; facial abnormalities; uncoercible vomiting or hypersecretion of the airways; use of continuous NIPPV or HFNC for more than 8 hours before randomization; pregnancy; refusal to participate |
Interventions | Intervention group (HFNC): Airvo2, Fisher & Paykel Control group (NIV): BiPAP; oronasal or full face mask |
Outcomes | All outcomes measured: recruitment feasibility; dyspnoea (Borg scale); respiratory rate; oxygenation; PaCO2 Outcomes relevant to this review: dyspnoea (Borg scale); respiratory rate; oxygenation; PaCO2 |
Starting date | 5 February 2020 |
Contact information | Leticia Kawano‐Dourado, ldourado@hcor.com.br. Karina Negrelli, knegrelli@hcor.com.br |
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