NCT06671015 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
| NCT ID | NCT06671015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Systolic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-04 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-10-04 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
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)
Contact & Investigator
Elliott Miller, MD, MS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06671015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systolic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671015 currently recruiting?
Yes, NCT06671015 is actively recruiting participants. Contact the research team at elliott.miller@yale.edu for enrollment information.
Where is the NCT06671015 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06671015 clinical trial?
NCT06671015 is sponsored by Yale University. The principal investigator is Elliott Miller, MD, MS at Yale University. The trial plans to enroll 50 participants.
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