High-Flow Nasal Cannula vs Noninvasive Ventilation for Heart Failure
(EXTUBATE-HF Trial)

Recruiting in Palo Alto (17 mi)

Overseen byElliott Miller, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients at Yale New Haven Hospital with systolic heart failure (heart pump weakness) who needed a breathing tube and are in the cardiac or medical ICU. They must have an ejection fraction (a measure of heart strength) ≤40%. Specific criteria to join or reasons to be excluded aren't listed.

Inclusion Criteria

I am an adult over 18 and not pregnant.

The patient is ventilated for greater than 24 hours

My heart's pumping ability is reduced (EF ≤ 40%).

+1 more

Exclusion Criteria

I am currently being treated for a severe COPD flare-up or have high carbon dioxide levels in my blood.

Patients in an agitated or uncooperative state

Patients who are prisoners

+4 more

Participant Groups

The study compares two ways to help patients breathe after removing their breathing tubes: high-flow nasal cannula, which delivers oxygen through the nose, versus non-invasive ventilation, which uses a mask to support breathing.

2Treatment groups

Experimental Treatment

Active Control

Group I: Extubation to HFNCExperimental Treatment1 Intervention

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.

Group II: Control: Extubation to NIV for 24hrs post-extubation.Active Control1 Intervention

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