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

NCT04269681 | Terminated

• 1 other identifier: IP-HCOR/RENOVATEpaliativo
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non invasive ventilation; high flow nasal cannula; palliative; dypnea; standard care; do-not-intubate; acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• Dypnea

  Variation in dyspnea according to the Borg scale in 48 hours.

  48 hours

Secondary Outcomes (6)

• Comfort

  48 hours

• Dose of Opioid

  48 hours

• Delirium

  48 hours

• Intensive Care Unit (ICU) stay

  28 days

• Mortality

  28 days

Study Arms (2)

High Flow Nasal Cannula Arm

EXPERIMENTAL

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

Standard respiratory support

ACTIVE COMPARATOR

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

Interventions

High Flow Nasal Cannula DEVICE

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.

Also known as: High Flow Oxygen, Airvo, Optiflow, Nasal High Flow

High Flow Nasal Cannula Arm

Standard respiratory support OTHER

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.

Also known as: NIV, Low flow Oxygen, Non-invasive positive pressure ventilation, Noninvasive positive pressure ventilation, Oxygen supplementation

Standard respiratory support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Dyspnea (defined on the Borg scale ≥4);
• SpO2 \<90% or paO2 \<60 mmHg in room air;
• Absence of delirium;
• One of the following:
• A. Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .

You may not qualify if:

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

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ministry of Health, Brazil: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Hospital Nereu Ramos

Florianópolis, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Alexandre B Cavalcanti, MD

  Hospital do Coracao

  STUDY DIRECTOR

• Lara P Kretzer, MD

  HU UFSC

  PRINCIPAL INVESTIGATOR

• Leticia Kawano-Dourado, MD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Israel S Maia, MD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Fernando Zampieri, MD

  Hospital do Coracao

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will have no access to randomisation list and won't be able to guess which group participant was allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised for 2 groups: high flow nasal cannula or standard care with no crossover between them.

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: December 1, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol, SAP and Informed Consent will be available in april 2021
• Access Criteria: Publication

Locations

BR (1)