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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06671015
Status
Recruiting
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Conditions

  • Respiratory Failure
  • Systolic Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Airvo 3 — DEVICE
    Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.

Study Details

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)

Key Dates

Start date
Oct 4, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital (CICU or MICU)New HavenConnecticut06520-

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital (CICU or MICU)· New Haven, CT

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