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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Page 1 of 1 (1 locations)

1

Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, United States, 06520

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 | DecenTrialz