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Recruiting 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

No phase Interventional Systolic Heart Failure Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Airvo 3.
Who it may be relevant to
Registry conditions: Systolic Heart Failure, Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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.

Interventions

  • Device Airvo 3
    Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.

Primary outcome measures

  • Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation [Time frame: up to 72 hours post-extubation]
Secondary outcome measures (7)
  • Incidence of Reintubation or respiratory failure [Time frame: 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)]
  • Patient intolerance to assigned treatment [Time frame: up to 24 hours post-extubation]
  • Mean length of stay [Time frame: up to 30 days post-extubation]
  • Incidence of ICU mortality [Time frame: up to ICU discharge (an average of 30 days post-extubation)]
  • Hospital mortality [Time frame: 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation)]
  • Time to reintubation [Time frame: Immediately post-extubation up to 30 days post-extubation]
  • Respiratory rate-oxygenation (ROX) index and vector [Time frame: on day of extubation]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Yale New Haven Hospital (CICU or MICU) — New Haven

Identifiers

NCT: NCT06671015 · 2000038572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗