High-flow nasal cannula versus noninvasive ventilation after extubation in people with systolic heart failure

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 pilot will test whether high-flow nasal cannula or noninvasive ventilation after extubation better prevents reintubation in adults with systolic heart failure who were on a ventilator.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06671015 on ClinicalTrials.gov

What this trial studies

This is an open-label, randomized 1:1 pilot trial at Yale New Haven Hospital enrolling adults with systolic heart failure (ejection fraction ≤40%) who have been mechanically ventilated for more than 24 hours and are ready for planned extubation. Participants are randomized to extubation supported by either high-flow nasal cannula (HFNC) or noninvasive ventilation (NIV) using the Airvo 3 device. The primary outcomes are rates of reintubation and post-extubation respiratory failure, with reintubation decisions made by the attending physician. Results will inform the design and power calculations for a larger randomized controlled trial.

Who should consider this trial

Good fit: Adults (≥18) with systolic left ventricular dysfunction (ejection fraction ≤40%) who have been mechanically ventilated for more than 24 hours and are ready for planned extubation in the CICU or MICU are ideal candidates.

Not a fit: Patients with active COPD exacerbation or chronic hypercapnia, pre-existing NIV prescriptions, tracheostomies, do-not-resuscitate orders, agitation or inability to cooperate, prisoners, or those who self-extubate are excluded and unlikely to benefit from the study interventions.

Why it matters

Potential benefit: If successful, this approach could reduce reintubation rates and respiratory complications after extubation in people with systolic heart failure.

How similar studies have performed: Prior ICU trials comparing HFNC and NIV in mixed patient groups have shown mixed but often encouraging results, but randomized data specifically in high-risk systolic heart failure patients are limited.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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)

Where this trial is running

New Haven, Connecticut

• Yale New Haven Hospital (CICU or MICU) — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Elliott Miller, MD, MS — Yale University
• Study coordinator: Elliott Miller, MD, MS

Conditions: Systolic Heart Failure, Respiratory Failure