RecruitingNot ApplicableNCT06671015

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

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


Sponsor

Yale University

Enrollment

50 participants

Start Date

Oct 4, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two breathing support methods — high-flow nasal cannula (warm, humidified oxygen delivered through a nose tube) versus noninvasive ventilation (a face mask that pushes air into the lungs) — for preventing breathing failure and re-intubation after patients with heart failure are taken off a breathing machine (extubated). **You may be eligible if...** - You are 18 or older - You have been on a ventilator for more than 24 hours - You have heart failure with reduced pumping function (ejection fraction ≤ 40%) **You may NOT be eligible if...** - You are being treated for a COPD flare-up or have high carbon dioxide levels in your blood - You are agitated or uncooperative - You have a do-not-resuscitate order - You have a tracheostomy or face anatomy that prevents using a breathing mask - You are a prisoner - You removed your own breathing tube - You already use noninvasive ventilation at home (e.g., for sleep apnea) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAirvo 3

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


Locations(1)

Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, United States

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NCT06671015


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