Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06671015

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Systolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Airvo 3

Device

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

Primary outcomes

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

    Time frame: up to 72 hours post-extubation

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

Secondary outcomes

  1. Incidence of Reintubation or respiratory failure

    Time frame: 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)

    Number of participants that experience reintubation or respiratory failure (per specific, predetermined criteria) within 48 hours, 7 days, and up to ICU discharge (an average of 30 days)

  2. Patient intolerance to assigned treatment

    Time frame: up to 24 hours post-extubation

    Intolerance will be measured as the ability to continue the therapy for the 24 hour treatment period (yes/no).

  3. Mean length of stay

    Time frame: up to 30 days post-extubation

    Mean length of ICU and hospital stay in days

  4. Incidence of ICU mortality

    Time frame: up to ICU discharge (an average of 30 days post-extubation)

    Number of participants with mortality while in ICU

  5. Hospital mortality

    Time frame: 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)

    Number of participants with mortality while in hospital

  6. Time to reintubation

    Time frame: Immediately post-extubation up to 30 days post-extubation

    Mean number of hours to reintubation after extubation

  7. Respiratory rate-oxygenation (ROX) index and vector

    Time frame: on day of extubation

    The ROX index, defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ fraction of inspired oxygen (FIO2) to respiratory rate (RR), is used as a predictor of the need to intubate in patients that received HFNC oxygen therapy. Low ROX index (< 3): Indicates a higher risk of HFNC failure. High ROX index (> 4.88): Suggests a lower risk of HFNC failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Elliott Miller, MD, MS

CONTACT

[email protected]

203-737-6390

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Fisher & Paykel Healthcare Limited

Registry information

Official study title

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

Acronym: EXTUBATE-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.