An interventional study of Airvo 3 in Systolic Heart Failure and Respiratory Failure, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
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:
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.
227 studies on the registry are indexed under Heart Failure, Systolic; 50 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 162 interventional studies indexed under Heart Failure, Systolic.
Browse Heart Failure, Systolic studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Immediately after planned extubation, the patients assigned to the HFNC group will be continuously treated by HFNC at a flow at the maximally tolerated level for 24 hours.
Device: Airvo 3
The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours.
Device: Airvo 3
Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation.
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
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
Plan to share: No
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