Clinical trial NCT06671015: 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
Official title: A Prospective Randomized Controlled Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systolic Heart Failure
Respiratory Failure
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Fisher & Paykel Healthcare Limited
First posted: 2024-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for \>24 hours.
Primary purpose: SUPPORTIVE_CARE

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 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)

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 at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.

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)

Primary outcomes:
measure: Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation
timeFrame: up to 72 hours post-extubation
Secondary outcomes:
measure: Incidence of Reintubation or respiratory failure
timeFrame: 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)
measure: Patient intolerance to assigned treatment
timeFrame: up to 24 hours post-extubation
measure: Mean length of stay
timeFrame: up to 30 days post-extubation
measure: Incidence of ICU mortality
timeFrame: up to ICU discharge (an average of 30 days post-extubation)
measure: Hospital mortality
timeFrame: 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)
measure: Time to reintubation
timeFrame: Immediately post-extubation up to 30 days post-extubation
measure: Respiratory rate-oxygenation (ROX) index and vector
timeFrame: on day of extubation
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital (CICU or MICU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Elliott Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: