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

Not Applicable

Terminated

• Conditions: Care, Palliative; Respiratory Failure
• Interventions: Device: High Flow Nasal Cannula; Other: Standard respiratory support

• Registration Number: NCT04269681
• Lead Sponsor: Hospital do Coracao

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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2020-12-01
• Status Verified: 2021-08
• Primary Completion: 2021-08-09
• Study Completion: 2021-08-09
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Flow Nasal Cannula Arm	High Flow Nasal Cannula	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.
Standard respiratory support	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.

Primary Outcome Measures

Name	Time	Method
Dypnea	48 hours	Variation in dyspnea according to the Borg scale in 48 hours.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Nereu Ramos; 🇧🇷 Florianópolis, SC, Brazil