Status:
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
Lead Sponsor:
Yale University
Collaborating Sponsors:
Fisher & Paykel Healthcare Limited
Conditions:
Systolic Heart Failure
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be ...
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)
Key Trial Info
Start Date :
October 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06671015
Start Date
October 4 2025
End Date
February 1 2026
Last Update
November 13 2025
Active Locations (1)
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1
Yale New Haven Hospital (CICU or MICU)
New Haven, Connecticut, United States, 06520