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

NCT04253405 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-08-16

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Fisher and Paykel Healthcare

    collaborator INDUSTRY

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Leticia Kawano-Dourado, MD · Hospital do Coração

  • Israel Maia, MD · Hospital do Coração

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-08-09
Completion
2021-08-09

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253405 on ClinicalTrials.gov