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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

ConditionsSystolic Heart FailureRespiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Airvo 3

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Extubation to HFNCExperimental treatment 1 intervention
Group B: Control: Extubation to NIV for 24hrs post-extubation.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
up to 72 hours post-extubation

Secondary outcomes

1

Incidence of Reintubation or respiratory failure

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)

Time frame
48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation)
2

Patient intolerance to assigned treatment

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

Time frame
up to 24 hours post-extubation
3

Mean length of stay

Mean length of ICU and hospital stay in days

Time frame
up to 30 days post-extubation
4

Incidence of ICU mortality

Number of participants with mortality while in ICU

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Fisher & Paykel Healthcare Limited

Collaborator

Source ClinicalTrials.gov
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