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 (EXTUBATE-HF)

Yale University

Status: Not yet enrolling

Conditions: Respiratory Failure; Systolic Heart Failure

Treatments: Device: Airvo 3

Study type: Interventional

Funder types: Other

Identifiers

NCT06671015

2000038572

Details and patient eligibility

About

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)

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Extubation to HFNC

Experimental group

Description:

Immediately after planned extubation, the patients assigned to the HFNC group will be continuously treated by HFNC at a flow at the maximally tolerated level for 24 hours.

Treatment:

Device: Airvo 3

Control: Extubation to NIV for 24hrs post-extubation.

Active Comparator group

Description:

The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours.

Treatment:

Device: Airvo 3