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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

RecruitingNAAges 18 Years - anyAllYale University
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค40%, 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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • Airvo 3
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Where

1 site
Yale New Haven Hospital (CICU or MICU)
New Haven, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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