Recruiting

HFNC & NIV

Sponsor:

Yale University

Code:

NCT06671015

Conditions

Systolic Heart Failure

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Airvo 3

Study Details

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

Study ID

NCT06671015

Start date

Oct 4, 2025

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Extubation to HFNC

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.

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

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

Interventions

Airvo 3

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

Primary outcome measure

  • Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation [ Time Frame: up to 72 hours post-extubation ]

Central Contacts and Locations

Central contacts

Elliott Miller, MD, MS

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

Locations

Yale New Haven Hospital (CICU or MICU)

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-28.