Respiratory Failure, Systolic Heart Failure
Conditions
Brief summary
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
DEVICEAirvo 3
Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.
Sponsors
Yale University
Fisher & Paykel Healthcare Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for \>24 hours.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation | up to 72 hours post-extubation | Number of participants with reintubation or respiratory failure within 72 hours post-extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Reintubation or respiratory failure | 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation) | 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) |
| Patient intolerance to assigned treatment | up to 24 hours post-extubation | Intolerance will be measured as the ability to continue the therapy for the 24 hour treatment period (yes/no). |
| Mean length of stay | up to 30 days post-extubation | Mean length of ICU and hospital stay in days |
| Incidence of ICU mortality | up to ICU discharge (an average of 30 days post-extubation) | Number of participants with mortality while in ICU |
| Hospital mortality | 48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation) | Number of participants with mortality while in hospital |
| Time to reintubation | Immediately post-extubation up to 30 days post-extubation | Mean number of hours to reintubation after extubation |
| Respiratory rate-oxygenation (ROX) index and vector | on day of extubation | 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. |
Countries
United States
Contacts
CONTACTElliott Miller, MD, MS
PRINCIPAL_INVESTIGATORElliott Miller, MD, MS
Yale University
Outcome results
None listed