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

Yale University50 enrolled

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Systolic Heart Failure Respiratory Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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)

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

Mean length of stay

Mean length of ICU and hospital stay in days

Time frame: up to 30 days post-extubation

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)

Hospital mortality

Number of participants with mortality while in hospital

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

Time to reintubation

Mean number of hours to reintubation after extubation

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

Respiratory rate-oxygenation (ROX) index and vector

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.

Time frame: on day of extubation