Acute Respiratory FailureFibrosisNCT04253405
RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis
A study testing High Flow Nasal Catheter and Noninvasive positive pressure ventilation (NIPPV) in people with Acute Respiratory Failure and Pulmonary Fibrosis, run by Hospital do Coracao at 6 sites in Brazil.
Trial summary
A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Pulmonary Fibrosis
- What is being tested?
- High Flow Nasal Catheter and Noninvasive positive pressure ventilation (NIPPV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 6 sitesBrazil
- Study dates
- 10 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
None listed.
Who cannot join
- Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
- Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index <2L / min / m2 in catheterization of right chambers;
- Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
- Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
- Presence of delirium or non-cooperation at the time of randomization;
- Anatomical facial abnormalities;
Show all 10Show fewer
- Incoercible vomiting or hypersecretion of the airways;
- Use of continuous VNIPP or HFNC for more than 8h before randomization;
- pregnancy;
- Refusal to participate.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital de Brasilia (HOBRA)
Brasília, Federal District
Hospital Nereu Ramos
Florianópolis, Santa Catarina
Instituto de Cardiologia Dante Pazanese
São Paulo, São Paulo
Hospital do Coracao
São Paulo
InCor - Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo
Hospital UNIMED Vitória
Vitória, Espírito Santo
About this study
Official title: Multicentric Randomized Controlled Pilot Study Comparing High Flow Nasal Cannula Versus NonInvasive Positive Pressure Ventilation in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (RENOVATE Fibrosis)
A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.
Read the detailed description
RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.
- Conditions
- Acute Respiratory Failure, Pulmonary Fibrosis
- Being tested
- High Flow Nasal Catheter, Noninvasive positive pressure ventilation (NIPPV)
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CatheterDevice
Also called Optiflow, Airvo, trans-nasal insufflation, Nasal High Flow
HFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees.
Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2
Noninvasive positive pressure ventilation (NIPPV)Device
Also called BiPAP, Non-invasive ventilation, Non-invasive positive pressure ventilation
NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula (HFNC) | Active comparator | The HFNC (Airvo2 Fisher \& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min. Receives: Device: High Flow Nasal Catheter |
| Non-invasive positive pressure ventilation (NIPPV) | Active comparator | NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or an invasive mechanical ventilator with NIPPV mode are accepted. The interface should be an oronasal or full face mask. Receives: Device: Noninvasive positive pressure ventilation (NIPPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
Measured: 18 months
Secondary outcomes (4)
Dyspneia variation (Borg scale)
Borg scale
Measured: 7 days
Respiratory frequency variation
Respiratory rate
Measured: 7 days
oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
Oxygen index
Measured: 7 days
Carbon dioxide arterial partial pressure (PaCO2) variation
CO2 variation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Dec 2020
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Why it stopped: Study impacted by the COVID-19 pandemic: * slow recruitment rate * budget constrains
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- 1:1 randomized controlled study
- Masking
- None (open label)
- 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
- Leticia Kawano-Dourado, MD, Principal investigator, Hospital do CoraçãoIsrael Maia, MD, Principal investigator, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253405
- Sponsor's protocol ID
- IP-HCOR/RENOVATEfibrose
- Acronym
- Fibrosis
- Status last verified
- Aug 2021
- First submitted
- 31 Jan 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: Data sharing plan - 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
- Multicentric Randomized Controlled Pilot Study Comparing High Flow Nasal Cannula Versus NonInvasive Positive Pressure Ventilation in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (RENOVATE Fibrosis)
- ClinicalTrials.gov ID
- NCT04253405
- Acronym / sponsor ID
- Fibrosis / IP-HCOR/RENOVATEfibrose
- Conditions
- Acute Respiratory Failure, Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study impacted by the COVID-19 pandemic: * slow recruitment rate * budget constrains
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fisher and Paykel Healthcare
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 5 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.
A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.
Detailed description
RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula (HFNC) | Active comparator | Device: High Flow Nasal CatheterThe HFNC (Airvo2 Fisher \& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min. |
| Non-invasive positive pressure ventilation (NIPPV) | Active comparator | Device: Noninvasive positive pressure ventilation (NIPPV)NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or an invasive mechanical ventilator with NIPPV mode are accepted. The interface should be an oronasal or full face mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;
- Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index <2L / min / m2 in catheterization of right chambers;
- Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;
- Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;
- Presence of delirium or non-cooperation at the time of randomization;
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 CatheterAlso: Optiflow, Airvo, trans-nasal insufflation, Nasal High FlowHFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees. Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2 | Device | High Flow Nasal Cannula (HFNC) |
| Noninvasive positive pressure ventilation (NIPPV)Also: BiPAP, Non-invasive ventilation, Non-invasive positive pressure ventilationNIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol. | Device | Non-invasive positive pressure ventilation (NIPPV) |
Primary outcome
Recruitment feasibility
Time frame: 18 months
Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months
4 secondary outcomes
Dyspneia variation (Borg scale)
Time frame: 7 days
Respiratory frequency variation
Time frame: 7 days
oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation
Time frame: 7 days
Carbon dioxide arterial partial pressure (PaCO2) variation
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Study impacted by the COVID-19 pandemic: * slow recruitment rate * budget constrains). 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. Data sharing plan - under construction
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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.
Leticia Kawano-Dourado, MD principal investigator
Hospital do Coração
Israel Maia, MD principal investigator
Hospital do Coração
6 sites 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 Catheter and Noninvasive positive pressure ventilation (NIPPV) in people with Acute Respiratory Failure and Pulmonary Fibrosis, run by Hospital do Coracao at 6 sites 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 0 inclusion and 10 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 6 sites 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: Study impacted by the COVID-19 pandemic: * slow recruitment rate * budget constrains). 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?
Recruitment feasibility (time frame: 18 months). 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.