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New study tests which breathing aid works best for heart failure patients coming off ventilators

NCT ID NCT06671015

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two breathing support methods—high-flow nasal cannula (HFNC) and non-invasive ventilation (NIV)—in heart failure patients after their breathing tube is removed. The goal is to see which method better prevents the need for re-insertion of the breathing tube or respiratory failure within 72 hours. The trial will enroll 50 high-risk patients with systolic heart failure at Yale New Haven Hospital.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-flow nasal cannula (HFNC) and non-invasive ventilation (NIV) devices
What this could lead to
If it works, this could show that high-flow nasal cannula is a better or equally effective way to prevent reintubation in heart failure patients, potentially improving recovery and reducing complications.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to all patients. The open-label design means both doctors and patients know which treatment is given, which could bias outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

respiratory failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory failure Systolic heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale New Haven Hospital (CICU or MICU)

    RECRUITING

    New Haven, Connecticut, 06520, United States

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