High-Flow Nasal Oxygen Cannula Compared to Non-Invasive Ventilation in Adult Patients With AcuTE Respiratory Failure

Summary

RENOVATE study aims to investigate if the respiratory support device called High-Flow Nasal Oxygen Cannula (HFNC) acts similarly (non-inferior) to another respiratory support device called Non-Invasive positive-pressure Ventilation (NIPPV) in preventing endotracheal intubation in adult patients with Acute Respiratory Failure (ARF) from different causes. HFNC is a somewhat new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is that, even though NIPPV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same beneficial effect of NIPPV while being easier tolerated, allowing patients to talk, eat and drink through mouth while on HFNC. RENOVATE will recruit between 800 to 2000 patients (adaptive design) with different types of ARF in Brazil. Patients will be randomized to HFNC or NIPPV and the rate of endotracheal intubation will be compared between groups as well as other parameters such as vital status and other health care related complications.

\[IMPORTANT NOTE\] On April 13, 2021, on the first interim analysis, the DSMB recommended the interruption of the immunocompromised hypoxemic ARF subgroup.

Conditions

• Respiratory Insufficiency
• Respiratory Failure

Interventions

DEVICE

High Flow Nasal Catheter

HFNC will deliver 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 patient´s comfort and SpO2.

DEVICE

Noninvasive ventilation

NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 tailored to specific ARF subgroups, according to the protocol. Adjustments of the inspiratory pressure (IPAP) and expiratory pressure (EPAP) and FiO2 according to protocol

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Berry Consultants

  collaborator OTHER

• Hospital do Coracao

  lead OTHER

Principal Investigators

• Alexandre B Cavalcanti, MD · Research Institute - Hospital do Coracao, Sao Paulo, Brazil

• Israel Maia, MD · Research Institute - Hospital do Coracao, Sao Paulo, Brazil

• Leticia Kawano-Dourado, MD · Research Institute - Hospital do Coracao, Sao Paulo, Brazil

• Laurent Brochard, MD · St. Michael's Hospital (Toronto, Canada)

• Carlos R Carvalho, MD · Pulmonary Division University of Sao Paulo, Sao Paulo, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2023-11-30

Completion

2024-02-28

Countries

• Brazil

Study Locations