Actively Recruiting
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
Led by Yale University · Updated on 2025-11-13
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
F
Fisher & Paykel Healthcare Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 years or older
- Ventilated for more than 24 hours
- Systolic left ventricular dysfunction with ejection fraction 40% or less
- Provided written informed consent approved by Institutional Review Board or Ethics Committee
You will not qualify if you...
- Currently treated for COPD exacerbation or known high carbon dioxide levels (PaCO2 > 45) on last arterial blood gas
- Agitated or uncooperative state
- Do-not-resuscitate orders
- Tracheostomy or anatomical abnormalities interfering with mask fit
- Prisoner status
- Self-extubation
- Pre-existing noninvasive ventilation prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital (CICU or MICU)
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
E
Elliott Miller, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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