High-Flow Nasal Cannula vs Noninvasive Ventilation for Heart Failure

(EXTUBATE-HF Trial)

Overseen By Elliott Miller, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: COPD, Hypercapnia, Agitated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which breathing support is more effective for individuals with heart failure who have used a breathing machine for over a day. Participants will use either a high-flow nasal cannula (a tube delivering oxygen through the nose) or non-invasive ventilation (a mask assisting with breathing) for 24 hours after machine removal. The trial targets those with heart failure characterized by reduced pumping ability (ejection fraction of 40% or less) and who are in intensive care. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance future heart failure treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods are safe for heart failure patients?

Research has shown that the high-flow nasal cannula (HFNC) is generally safe for people with breathing problems. Studies have found that HFNC can improve oxygen levels and reduce the need for intubation, which involves placing a tube in the airway. This indicates that patients usually tolerate it well.

Some studies also report that HFNC can improve heart rate and blood pressure. However, safety and side effects can vary. Overall, HFNC is considered a safe option, especially compared to other breathing support methods.

Noninvasive ventilation (NIV) is a common treatment for assisting breathing. It is widely used and has a well-known safety record. Most patients handle it well, although some may find the mask uncomfortable.

Both HFNC and NIV assist with breathing without requiring tube insertion down the throat. They are considered safe, with HFNC showing promising results in improving breathing and reducing the need for intubation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) for heart failure because they offer unique ways to support breathing without the need for invasive procedures. Unlike traditional treatments that often rely on invasive mechanical ventilation, HFNC delivers warmed and humidified oxygen at high flow rates directly into the nose, which can be more comfortable and easier for patients to tolerate. On the other hand, NIV uses a mask to help push air into the lungs, providing support without the risks associated with intubation. Both methods aim to improve patient outcomes by reducing respiratory distress and promoting quicker recovery after extubation, offering promising alternatives to standard care.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare high-flow nasal cannula (HFNC) with noninvasive ventilation (NIV) for patients with heart failure. Research has shown that HFNC can reduce the need for reintubation and improve health outcomes in patients with sudden heart failure. It also enhances heart rate, breathing rate, and oxygen levels. Additionally, HFNC has demonstrated better oxygen levels and overall hospital results compared to traditional methods. These findings suggest HFNC could be a helpful option for managing heart failure after removing a breathing tube. Participants in this trial will be assigned to either the HFNC group or the NIV group to evaluate these outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Elliott Miller, MD, MS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for patients at Yale New Haven Hospital with systolic heart failure (heart pump weakness) who needed a breathing tube and are in the cardiac or medical ICU. They must have an ejection fraction (a measure of heart strength) ≤40%. Specific criteria to join or reasons to be excluded aren't listed.

Inclusion Criteria

The patient is ventilated for greater than 24 hours

My heart's pumping ability is reduced (EF ≤ 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)

Exclusion Criteria

Patients in an agitated or uncooperative state

I am currently being treated for a severe COPD flare-up or have high carbon dioxide levels in my blood.

Patients who are prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to extubation to either high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) for 24 hours post-extubation

24 hours

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for reintubation, respiratory failure, and other outcomes up to ICU discharge

up to 30 days

Regular monitoring during hospital stay

Long-term follow-up

Participants are monitored for hospital mortality and mean length of stay

up to 30 days post-extubation

What Are the Treatments Tested in This Trial?

Interventions

• High-Flow Nasal Cannula
• Noninvasive Ventilation

Trial Overview The study compares two ways to help patients breathe after removing their breathing tubes: high-flow nasal cannula, which delivers oxygen through the nose, versus non-invasive ventilation, which uses a mask to support breathing.

How Is the Trial Designed?

Group I: Extubation to HFNC Experimental Treatment 1 Intervention

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.

Group II: Control: Extubation to NIV for 24hrs post-extubation. Active Control 1 Intervention

The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Fisher & Paykel Healthcare Limited

Collaborator

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10685599/

Efficacy of high-flow nasal cannula in patients with acute heart ... Compared with COT, HFNC effectively reduced the intubation rate and provided greater clinical benefits to patients with AHF.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1555415523001046

High-Flow Nasal Cannula Oxygen Therapy in Patients With ... We found that HFNC use in patients with AHF resulted in a significant improvement in their heart rate, respiratory rate, brain natriuretic peptide level, oxygen ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2022/10280/clinical_outcomes_of_high_flow_nasal_cannula.60.aspx

Clinical outcomes of high-flow nasal cannula oxygen ... Changes of left ventricular function parameters, ABG and clinical outcomes were all improved satisfactorily after 24 h medical interventions in ...

4. jtd.amegroups.org jtd.amegroups.org/article/view/26695/html

Clinical efficacy of high-flow oxygen therapy through nasal ... This study showed HFNC group had a similar result of improvement of oxygen saturation and in-hospital clinical outcomes compared with intubation group in AHF.

5. accjournal.org accjournal.org/journal/view.php?doi=10.4266/acc.2021.01571

High-flow nasal cannula for respiratory failure in adult ... While data are conflicting, these studies consistently demonstrate improved oxygenation and a decreased need for intubation when HFNC is used ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9622568/

Clinical outcomes of high-flow nasal cannula oxygen therapy ... Purpose of this study was to evaluated the physiological responses and clinical outcomes of HFNC by comparing with noninvasive positive pressure ventilation ( ...

7. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02782-0

Efficacy of high-flow nasal cannula in patients with acute heart ... Compared with COT, HFNC effectively reduced the intubation rate and provided greater clinical benefits to patients with AHF.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147956323001103

Cardiopulmonary outcomes following high flow nasal ... Other notable outcomes in HFNC patients included normalizing heart rate, partial blood pressure, and PaO2/FiO2 ratio. However, some studies reported a ...