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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

NCT ID: NCT06671015

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-04

Study Completion Date

2026-02-28

Brief Summary

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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)

Detailed Description

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The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.

Conditions

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Systolic Heart Failure Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for \>24 hours.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Airvo 3

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Airvo 3

Intervention Type DEVICE

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

Interventions

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Airvo 3

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Fisher & Paykel Healthcare Limited

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Elliott Miller

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elliott Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elliott Miller, MD, MS

Role: CONTACT

Phone: 203-737-6390

Email: [email protected]

Other Identifiers

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2000038572

Identifier Type: -

Identifier Source: org_study_id