RENOVATE Palliative: HFNC vs. Standard Respiratory Support in Patients With Do-Not-Intubate Order and ARF

Summary

Randomized clinical trial in which the main objective is to compare High Flow Nasal Cannula (HFNC) versus the standard respiratory care in the alleviation of dyspnea perception in patients with do-not-intubate (DNI) order. This is a pragmatic study that will take place in 10 Brazilians ICU facilities which are already participating in the main study RENOVATE NCT03643939.

Conditions

• Care, Palliative
• Respiratory Failure

Interventions

DEVICE

High Flow Nasal Cannula

Experimental intervention (HFNC) The HFNC (AIRVO 2 - Fisher \& Paykel Healthcare, Auckland, New Zealand) consists of a device that allows FiO2 adjustable from 21 to 100% and that delivers a flow of humidified and heated gas up to 60 l / min and 37 degrees C of temperature. The HFNC will be offered until resolution of the ARF or until decision by the assisting team and the patient and/or their legal guardian, for the suspension of the treatment due to intolerance, and/or worsening of the discomfort and / or dyspnea. The HFNC should be offered to the patient in ARF as follows: * Initial parameters: Flow 45 ml / L, FiO2 50%, AIRVO 37oC temperature; * Titrate the flow up to 60ml / L or up to the maximum tolerated; * Titrate FiO2 to maintain SatO2 between 92% to 98%, starting with 50%; * Keep the AIRVO temperature at 37oC, if not possible, acceptable down to 34oC.

OTHER

Standard respiratory support

The patient randomized to standard respiratory support will be placed on conventional low flow oxygen therapy according to the center's standard of care aiming at SpO2 90 - 98% and improvement of dyspnea. For cases refractory to oxygen therapy, keeping SpO2 below 90% or if dyspnea does not improve, non-invasive positive pressure ventilation (NIPPV) may be offered at the discretion of the assistant team. NIPPV will be performed with the patient in a supine position at 45 degrees. The mask will be facial (oronasal or full face) with an appropriate size for each patient and adapted in a way to minimize leakage. A hydrocolloid dressing can be placed over the nose in order to avoid ulcerations and increase comfort. The NIPPV will be performed with the help of a ventilator with inspiratory and expiratory circuits or with Bilevel devices with a single circuit and exhalation valve according to the availability of each center.

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Fisher and Paykel Healthcare

  collaborator INDUSTRY

• Hospital do Coracao

  lead OTHER

Principal Investigators

• Alexandre B Cavalcanti, MD · Hospital do Coracao

• Lara P Kretzer, MD · HU UFSC

• Leticia Kawano-Dourado, MD · Hospital do Coracao

• Israel S Maia, MD · Hospital do Coracao

• Fernando Zampieri, MD · Hospital do Coracao

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2021-08-09

Completion

2021-08-09

Countries

• Brazil

Study Locations