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

Renovate Palliative Study: Randomized Controlled Trial Comparing High Flow Nasal Catheter Versus Standard Respiratory Support in Patients With Do Not Intubate Order and Acute Respiratory Failure

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Failure; Care, Palliative
• Intervention / Treatment: Device: High Flow Nasal Cannula; Other: Standard respiratory support

Detailed Description

Do-not-intubate (DNI) is usually established in cases where endotracheal intubation (ETI) is considered disproportionate to prognosis and/or incompatible with the expression of wishes and values of the patient. Regardless of the profile of this care plan offered to patients with DNI, the control of dyspnea is one of its central objectives. The approach to dyspnea includes pharmacological measures such as opioids and non-pharmacological measures, such as oxygen therapy and Non-Invasive Ventilation, and more recently, the high flow nasal catheter (HFNC). HFNC provides high flow of heated and humidified mixed gas through a nasal cannula. In addition to the ability to generate high flows and supplemental oxygen, HFNC may generate a low level of positive airway pressure, may decrease dead space ventilation and may contribute to better patient comfort, such as the possibility of oral feeding while undergoing treatment, performing oral hygiene and allowing conversation and interaction with family members. This pilot study aims to evaluate the efficacy of HFNC in reducing dyspnea and improving comfort in patients with Acute Respiratory Failure (ARF) and DNI order.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SC
    • Florianópolis, SC, Brazil
      • Hospital Nereu Ramos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participants must be 18 years of age or older, with ARF of any cause on admission or post-extubation with prior DNI directives or DNI order determined in the current hospitalization.

Patients must meet the following criteria below:

1. Dyspnea (defined on the Borg scale ≥4);
2. SpO2 <90% or paO2 <60 mmHg in room air;
3. Absence of delirium;
4. One of the following:

A. Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .

Exclusion Criteria:

1. Refusal of treatment;
2. Agitation or non-cooperation;
3. Presence of delirium at the time of randomization;
4. Anatomical abnormalities that may interfere with the adjustment of the non-invasive positive pressure ventilation mask
5. Glasgow <12;
6. Psychomotor agitation that prevents adequate medical / nursing assistance requiring sedation;
7. Contraindications to NIV: uncontrollable vomiting, hypersecretion of the airways, facial deformities, trauma or extensive facial burn;
8. Presence of pneumothorax or extensive pleural effusion;
9. Expected imminent death, defined as an estimated death of less than 24 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Flow Nasal Cannula Arm; Participants will receive HFNC if they have no delirium and signs of ARF. The device is supposed to be used continuously in the nose with some changes in flow and/or temperature according to tolerance. There is no crossover to the standar of care arm.	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 Names: Optiflow; Airvo; Nasal High Flow; High Flow Oxygen
Active Comparator: Standard respiratory support; Participants will receive standard of care with low flow oxygen catheter or mask initially. If there is any sign of clinical deterioration NIV can be offered if tolerated by the patient. There will be no cross over with HFNC arm.	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.; Other Names: Noninvasive positive pressure ventilation; Oxygen supplementation; NIV; Non-invasive positive pressure ventilation; Low flow Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dypnea	Variation in dyspnea according to the Borg scale in 48 hours.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality in 28 days	28 days
Comfort	Comfort measured in a visual analogue scale from 0-100	48 hours
Dose of Opioid	Cumulative dose of opioid	48 hours
Delirium	Cumulative Delirium rate measured by CAM-ICU	48 hours
Intensive Care Unit (ICU) stay	total days inside the ICU	28 days
Usage of respiratory support devices	Total time in use of devices in both arms	48 hours

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Ministry of Health, Brazil; Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Leticia Kawano-Dourado, MD, Hospital do Coracao; Study Director: Alexandre B Cavalcanti, MD, Hospital do Coracao; Principal Investigator: Lara P Kretzer, MD, HU UFSC; Principal Investigator: Israel S Maia, MD, Hospital do Coracao; Study Chair: Fernando Zampieri, MD, Hospital do Coracao

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: non invasive ventilation; palliative; high flow nasal cannula; acute respiratory failure; dypnea; standard care; do-not-intubate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IP-HCOR/RENOVATEpaliativo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: under construction
• IPD Sharing Time Frame: Study protocol, SAP and Informed Consent will be available in april 2021
• IPD Sharing Access Criteria: Publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No