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

NCT06671015 | Recruiting FDA Device

• 1 other identifier: 2000038572
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Systolic Heart Failure; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation

  Number of participants with reintubation or respiratory failure within 72 hours post-extubation

  up to 72 hours post-extubation

Secondary Outcomes (7)

• Incidence of Reintubation or respiratory failure

  48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)

• Patient intolerance to assigned treatment

  up to 24 hours post-extubation

• Mean length of stay

  up to 30 days post-extubation

• Incidence of ICU mortality

  up to ICU discharge (an average of 30 days post-extubation)

• Hospital mortality

  48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)

Study Arms (2)

Extubation to HFNC

EXPERIMENTAL

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.

Device: Airvo 3

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

ACTIVE COMPARATOR

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

Device: Airvo 3

Interventions

Airvo 3 DEVICE

Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• Fisher & Paykel Healthcare Limited: collaborator

Study Sites (1)

Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Elliott Miller, MD, MS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elliott Miller, MD, MS

CONTACT

203-737-6390; elliott.miller@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for \>24 hours.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 4, 2024
• Study Start: October 4, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)