NCT04253405

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

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Respiratory Failure
• Pulmonary Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-08-09
• Completion: 2021-08-09
• First posted: 2020-02-05
• Last updated: 2021-08-16

Locations

6 sites across 1 country: Brazil