Systolic Heart FailureEXTUBATE-HFNCT06671015
A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
A study testing Airvo 3 in people with Systolic Heart Failure and Respiratory Failure, run by Yale University at 1 site in United States.
Trial summary
This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure, Respiratory Failure
- What is being tested?
- Airvo 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient is a male or non-pregnant female greater than or equal to 18 years of age
- The patient is ventilated for greater than 24 hours
- The patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40%
- The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
Who cannot join
- Patients actively being treated for a COPD exacerbation or known hypercapnia (PaCO2>45) on last Arterial Blood Gas (ABG)
- Patients agitated or uncooperative state
- Patients with do-not-resuscitate orders
- Patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit
- Patients are prisoners
- Patient self-extubates
- Patients with pre-existing NIV prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital (CICU or MICU)
New Haven, Connecticut, 06520
About this study
Official title: A Prospective Randomized Controlled Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or medical ICU (MICU) will be included.
Subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups:
- Intervention: Extubation to high-flow nasal cannula (HFNC)
- Control: Extubation to non-invasive ventilation (NIV)
Read the detailed description
The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.
- Conditions
- Systolic Heart Failure, Respiratory Failure
- Being tested
- Airvo 3
- Medical subject headings
- Heart Failure, Systolic, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airvo 3Device
Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.
| Study group | Role | What they receive |
|---|---|---|
| Extubation to HFNC | Experimental | Immediately after planned extubation, the patients assigned to the HFNC group will be continuously treated by HFNC at a flow at the maximally tolerated level for 24 hours. Receives: Device: Airvo 3 |
| Control: Extubation to NIV for 24hrs post-extubation. | Active comparator | The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours. Receives: Device: Airvo 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation
Number of participants with reintubation or respiratory failure within 72 hours post-extubation
Measured: up to 72 hours post-extubation
Secondary outcomes (7)
Incidence of Reintubation or respiratory failure
Number of participants that experience reintubation or respiratory failure (per specific, predetermined criteria) within 48 hours, 7 days, and up to ICU discharge (an average of 30 days)
Measured: 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)
Patient intolerance to assigned treatment
Intolerance will be measured as the ability to continue the therapy for the 24 hour treatment period (yes/no).
Measured: up to 24 hours post-extubation
Mean length of stay
Mean length of ICU and hospital stay in days
Measured: up to 30 days post-extubation
Incidence of ICU mortality
Number of participants with mortality while in ICU
Measured: up to ICU discharge (an average of 30 days post-extubation)
Hospital mortality
Number of participants with mortality while in hospital
Measured: 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)
Time to reintubation
Mean number of hours to reintubation after extubation
Measured: Immediately post-extubation up to 30 days post-extubation
Respiratory rate-oxygenation (ROX) index and vector
The ROX index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR), is used as a predictor of the need to intubate in patients that received HFNC oxygen therapy. Low ROX index (< 3): Indicates a higher risk of HFNC failure. High ROX index (> 4.88): Suggests a lower risk of HFNC failure.
Measured: on day of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start4 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for \>24 hours.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher & Paykel Healthcare Limited
- Responsible party
- Principal investigator, Elliott Miller, Yale University
- Investigators
- Elliott Miller, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671015
- Sponsor's protocol ID
- 2000038572
- Acronym
- EXTUBATE-HF
- Status last verified
- May 2026
- First submitted
- 28 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT06671015
- Acronym / sponsor ID
- EXTUBATE-HF / 2000038572
- Conditions
- Systolic Heart Failure, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Fisher & Paykel Healthcare Limited
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or medical ICU (MICU) will be included.
Subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups:
- Intervention: Extubation to high-flow nasal cannula (HFNC)
- Control: Extubation to non-invasive ventilation (NIV)
Detailed description
The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for >24 hours.
| Arm | Type | Receives |
|---|---|---|
| Extubation to HFNC | Experimental | Device: Airvo 3Immediately after planned extubation, the patients assigned to the HFNC group will be continuously treated by HFNC at a flow at the maximally tolerated level for 24 hours. |
| Control: Extubation to NIV for 24hrs post-extubation. | Active comparator | Device: Airvo 3The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is a male or non-pregnant female greater than or equal to 18 years of age
- The patient is ventilated for greater than 24 hours
- The patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40%
- The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
Key exclusion criteria (7 listed)
- Patients actively being treated for a COPD exacerbation or known hypercapnia (PaCO2>45) on last Arterial Blood Gas (ABG)
- Patients agitated or uncooperative state
- Patients with do-not-resuscitate orders
- Patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit
- Patients are prisoners
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 |
|---|---|---|
| Airvo 3Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation. | Device | Control: Extubation to NIV for 24hrs post-extubation., Extubation to HFNC |
Primary outcome
Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation
Time frame: up to 72 hours post-extubation
Number of participants with reintubation or respiratory failure within 72 hours post-extubation
7 secondary outcomes
Incidence of Reintubation or respiratory failure
Time frame: 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)
Patient intolerance to assigned treatment
Time frame: up to 24 hours post-extubation
Mean length of stay
Time frame: up to 30 days post-extubation
Incidence of ICU mortality
Time frame: up to ICU discharge (an average of 30 days post-extubation)
Hospital mortality
Time frame: 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)
Time to reintubation
Time frame: Immediately post-extubation up to 30 days post-extubation
Respiratory rate-oxygenation (ROX) index and vector
Time frame: on day of extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
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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.
Elliott Miller, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo 3 in people with Systolic Heart Failure and Respiratory Failure, run by Yale University at 1 site in United States.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elliott Miller, MD, MS (203-737-6390, elliott.miller@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation (time frame: up to 72 hours post-extubation). 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 28 May 2026.