Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06671015

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

Led by Yale University · Updated on 2026-05-28

50

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

F

Fisher & Paykel Healthcare Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two breathing support methods after planned extubation in patients with systolic heart failure who need invasive mechanical ventilation. The study focuses on people who have a heart condition with an ejection fraction of 40% or less and are admitted to intensive care units. It seeks to find out which method better prevents the need for reintubation or respiratory failure after removing the breathing tube. Participants will be randomly assigned to one of two groups after planned extubation: one group will receive continuous therapy using high-flow nasal cannula (HFNC) for 24 hours at the highest tolerated flow level, and the other group will receive non-invasive ventilation (NIV) with set ventilator settings for 24 hours. The study will take place at the Yale New Haven Hospital and is open-label, meaning both patients and researchers know the assigned treatment. During the study, researchers will monitor the rates of reintubation or respiratory failure within 72 hours after extubation as the primary outcome. Additional assessments include rates of respiratory failure at different time points, patient tolerance to treatments, length of hospital stay, ICU and hospital mortality, time to reintubation, and oxygenation measurements. Participants will be closely observed during the first 24 hours of treatment and followed up to 30 days post-extubation to gather comprehensive data on outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant female aged 18 years or older
  • Ventilated for more than 24 hours
  • Systolic left ventricular dysfunction with ejection fraction less than or equal to 40%
  • Provided written informed consent approved by Institutional Review Board or Ethics Committee
Not Eligible

You will not qualify if you...

  • Actively treated for COPD exacerbation or known high carbon dioxide levels (PaCO2 >45) on last arterial blood gas
  • Agitated or uncooperative state
  • Do-not-resuscitate orders
  • Presence of tracheostomy or anatomical abnormalities interfering with mask fit
  • Prisoners
  • Self-extubation
  • Pre-existing prescription for non-invasive ventilation (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 hours post-extubation

Participants undergo planned extubation and are randomly assigned to receive either high-flow nasal cannula (HFNC) therapy or noninvasive ventilation (NIV) for 24 hours post-extubation to support breathing.

1 treatment period immediately following extubation

Post-treatment Monitoring

Duration - Up to 30 days post-extubation

Participants are monitored for respiratory failure or reintubation and other clinical outcomes for up to 30 days after extubation.

Visits as needed up to 30 days

Trial Site Locations

Total: 1 location

1

Yale New Haven Hospital (CICU or MICU)

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

E

Elliott Miller, MD, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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