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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: elliott.miller@yale.edu
• Phone: 203-737-6390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.