Care, PalliativeNCT04269681
RENOVATE Palliative: HFNC vs. Standard Respiratory Support in Patients With Do-Not-Intubate Order and ARF
A study testing High Flow Nasal Cannula and Standard respiratory support in people with Care, Palliative and Respiratory Failure, run by Hospital do Coracao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care, Palliative, Respiratory Failure
- What is being tested?
- High Flow Nasal Cannula and Standard respiratory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2020to 9 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Care, Palliative, Respiratory Failure
- Being tested
- High Flow Nasal Cannula, Standard respiratory support
- Keywords
- non invasive ventilation, high flow nasal cannula, palliative, dypnea, standard care, do-not-intubate, acute respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
Also called High Flow Oxygen, Airvo, Optiflow, Nasal High Flow
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.
Standard respiratory supportOther
Also called NIV, Low flow Oxygen, Non-invasive positive pressure ventilation, Noninvasive positive pressure ventilation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dypnea
Variation in dyspnea according to the Borg scale in 48 hours.
Measured: 48 hours
Secondary outcomes (6)
Comfort
Comfort measured in a visual analogue scale from 0-100
Measured: 48 hours
Dose of Opioid
Cumulative dose of opioid
Measured: 48 hours
Delirium
Cumulative Delirium rate measured by CAM-ICU
Measured: 48 hours
Intensive Care Unit (ICU) stay
total days inside the ICU
Measured: 28 days
Mortality
Mortality in 28 days
Measured: 28 days
Usage of respiratory support devices
Total time in use of devices in both arms
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Dec 2020
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Why it stopped: Impacted by the COVID-19 pandemic: * slow recruitment rate * cuts in budget for non-COVID-19 related projects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care, PalliativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised for 2 groups: high flow nasal cannula or standard care with no crossover between them.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, Study director, Hospital do CoracaoLara P Kretzer, MD, Principal investigator, HU UFSCLeticia Kawano-Dourado, MD, Principal investigator, Hospital do CoracaoIsrael S Maia, MD, Principal investigator, Hospital do CoracaoFernando Zampieri, MD, Study chair, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269681
- Sponsor's protocol ID
- IP-HCOR/RENOVATEpaliativo
- Status last verified
- Aug 2021
- First submitted
- 12 Feb 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: under construction
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04269681
- Acronym / sponsor ID
- IP-HCOR/RENOVATEpaliativo
- Conditions
- Care, Palliative, Respiratory Failure
- Keywords
- non invasive ventilation, high flow nasal cannula, palliative, dypnea, standard care, do-not-intubate, acute respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impacted by the COVID-19 pandemic: * slow recruitment rate * cuts in budget for non-COVID-19 related projects
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fisher and Paykel Healthcare
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised for 2 groups: high flow nasal cannula or standard care with no crossover between them.
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula Arm | Experimental | Device: High Flow Nasal CannulaParticipants 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 | Active comparator | Other: Standard respiratory supportParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Dyspnea (defined on the Borg scale ≥4);
- SpO2 <90% or paO2 <60 mmHg in room air;
- Absence of delirium;
- One of the following:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal CannulaAlso: High Flow Oxygen, Airvo, Optiflow, Nasal High FlowExperimental 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. | Device | High Flow Nasal Cannula Arm |
| Standard respiratory supportAlso: NIV, Low flow Oxygen, Non-invasive positive pressure ventilation, Noninvasive positive pressure ventilationThe 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 | Standard respiratory support |
Primary outcome
Dypnea
Time frame: 48 hours
Variation in dyspnea according to the Borg scale in 48 hours.
6 secondary outcomes
Comfort
Time frame: 48 hours
Dose of Opioid
Time frame: 48 hours
Delirium
Time frame: 48 hours
Intensive Care Unit (ICU) stay
Time frame: 28 days
Mortality
Time frame: 28 days
Usage of respiratory support devices
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Impacted by the COVID-19 pandemic: * slow recruitment rate * cuts in budget for non-COVID-19 related projects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Yes. under construction
Related trials for Care, Palliative
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre B Cavalcanti, MD study director
Hospital do Coracao
Lara P Kretzer, MD principal investigator
HU UFSC
Leticia Kawano-Dourado, MD principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula and Standard respiratory support in people with Care, Palliative and Respiratory Failure, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Impacted by the COVID-19 pandemic: * slow recruitment rate * cuts in budget for non-COVID-19 related projects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dypnea (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.