Clinical trial NCT04269681: 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
Overall status: TERMINATED
Phase: NA
Conditions: Care, Palliative
Respiratory Failure
Keywords: non invasive ventilation
high flow nasal cannula
palliative
dypnea
standard care
do-not-intubate
acute respiratory failure
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: Fisher and Paykel Healthcare
First posted: 2020-02-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised for 2 groups: high flow nasal cannula or standard care with no crossover between them.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Dypnea
timeFrame: 48 hours
Secondary outcomes:
measure: Comfort
timeFrame: 48 hours
measure: Dose of Opioid
timeFrame: 48 hours
measure: Delirium
timeFrame: 48 hours
measure: Intensive Care Unit (ICU) stay
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: Usage of respiratory support devices
timeFrame: 48 hours
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Hospital Nereu Ramos
state: SC
Study officials:
affiliation: Hospital do Coracao
name: Alexandre B Cavalcanti, MD
role: STUDY_DIRECTOR
affiliation: HU UFSC
name: Lara P Kretzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Leticia Kawano-Dourado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Israel S Maia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Fernando Zampieri, MD
role: STUDY_CHAIR
References: