NCT06671015Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 4 Oct 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Yale University
- Diseases
- Heart failure
- NCT number
- NCT06671015
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 4 Oct 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with pre-existing NIV prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital (CICU or MICU) Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.