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Procedure

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

N/A

Waitlist Available

Led By Elliott Miller, MD, MS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40%

Be older than 18 years old

Must not have

Patients actively being treated for a COPD exacerbation or known hypercapnia (PaCO2>45) on last Arterial Blood Gas (ABG)

Patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day of extubation

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll patients at Yale New Haven Hospital who have systolic heart failure and require invasive mechanical ventilation. Participants will be randomly assigned to one of two treatment groups: one group will receive high-flow

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the devices, dryness or bleeding in the nose from HFNC, and possible skin irritation or pressure sores from NIV masks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a tracheostomy or a physical condition that affects how a mask fits.

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I have a prescription for a breathing device due to a condition like sleep apnea or COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Hospital mortality

Incidence of ICU mortality

Incidence of Reintubation or respiratory failure

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met