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

Trial Summary

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 data supports the effectiveness of the treatment High-Flow Nasal Cannula for heart failure?

Research shows that High-Flow Nasal Cannula (HFNC) can help patients with heart failure by reducing the need for intubation and improving oxygen levels. It is as effective as Noninvasive Ventilation (NIV) in preventing breathing problems after removing a breathing tube in heart failure patients. ^{1 2 3 4 5}

Is high-flow nasal cannula or noninvasive ventilation generally safe for humans?

Both high-flow nasal cannula and noninvasive ventilation can have lung-related complications, and there is a risk of adverse events if used improperly. However, they are widely used and generally considered safe when applied correctly in medical settings. ^{5 6 7 8 9}

How does the treatment of high-flow nasal cannula and noninvasive ventilation differ from other treatments for heart failure?

High-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) are unique because they provide respiratory support without the need for invasive procedures, like intubation. HFNC can improve breathing by delivering a high flow of oxygen through the nose, which may help reduce the heart's workload in heart failure patients. ^{2 5 6 10 11}

What is the purpose of this trial?

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)

Research Team

Elliott Miller, MD, MS

Principal Investigator

Yale University

Eligibility Criteria

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

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

Patients in an agitated or uncooperative state

Patients who are prisoners

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. [2019]

3. China pubmed.ncbi.nlm.nih.gov

Improved oxygenation 48 hours after high-flow nasal cannula oxygen therapy is associated with good outcome in immunocompromised patients with acute respiratory failure. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Clinical efficacy of high-flow oxygen therapy through nasal cannula in patients with acute heart failure. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patients with New York Heart Association class III heart failure may benefit with high flow nasal cannula supportive therapy: high flow nasal cannula in heart failure. [2022]

6. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula and noninvasive ventilation: effects on alveolar recruitment and overdistension. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Reintubation Within 24 Hours of Extubation in Bronchiolitis: Retrospective Cohort Study Using the Virtual Pediatric Systems Database. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Failure of High-Flow Nasal Cannula. [2021]

9. Egypt pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula in Hypercapnic Respiratory Failure: A Systematic Review and Meta-Analysis. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. [2022]