About this trial
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
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Airvo 3
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
Fisher & Paykel Healthcare Limited
Collaborator