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

Primary Purpose

Care, Palliative, Respiratory Failure

Status

Terminated

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

High Flow Nasal Cannula

Standard respiratory support

About this trial

This is an interventional treatment trial for Care, Palliative focused on measuring non invasive ventilation, high flow nasal cannula, palliative, dypnea, standard care, do-not-intubate, acute respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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 .

Exclusion Criteria:

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.

Sites / Locations

Hospital Nereu Ramos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Nasal Cannula Arm

Standard respiratory support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dypnea

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

Secondary Outcome Measures

Comfort

Comfort measured in a visual analogue scale from 0-100

Dose of Opioid

Cumulative dose of opioid

Delirium

Cumulative Delirium rate measured by CAM-ICU

Intensive Care Unit (ICU) stay

total days inside the ICU

Mortality

Mortality in 28 days

Usage of respiratory support devices

Total time in use of devices in both arms

Full Information

NCT ID

NCT04269681

First Posted

February 12, 2020

Last Updated

August 9, 2021

Sponsor

Hospital do Coracao

Collaborators

Ministry of Health, Brazil, Fisher and Paykel Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT04269681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

Impacted by the COVID-19 pandemic: slow recruitment rate cuts in budget for non-COVID-19 related projects

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

August 9, 2021 (Actual)

Study Completion Date

August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital do Coracao

Collaborators

Ministry of Health, Brazil, Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Care, Palliative, Respiratory Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

Outcome assessors will have no access to randomisation list and won't be able to guess which group participant was allocated to.

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Flow Nasal Cannula Arm

Arm Type

Experimental

Arm Description

Arm Title

Standard respiratory support

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

High Flow Nasal Cannula

Other Intervention Name(s)

High Flow Oxygen, Airvo, Optiflow, Nasal High Flow

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard respiratory support

Other Intervention Name(s)

NIV, Low flow Oxygen, Non-invasive positive pressure ventilation, Noninvasive positive pressure ventilation, Oxygen supplementation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Dypnea

Description

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

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Comfort

Description

Comfort measured in a visual analogue scale from 0-100

Time Frame

48 hours

Title

Dose of Opioid

Description

Cumulative dose of opioid

Time Frame

48 hours

Title

Delirium

Description

Cumulative Delirium rate measured by CAM-ICU

Time Frame

48 hours

Title

Intensive Care Unit (ICU) stay

Description

total days inside the ICU

Time Frame

28 days

Title

Mortality

Description

Mortality in 28 days

Time Frame

28 days

Title

Usage of respiratory support devices

Description

Total time in use of devices in both arms

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 . Exclusion Criteria: 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.

Overall Study Officials: