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| Name | Class |
|---|---|
| Fisher & Paykel Healthcare Limited | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extubation to HFNC | Experimental | 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. |
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| Control: Extubation to NIV for 24hrs post-extubation. | Active Comparator | The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airvo 3 | Device | Provides effective therapy for acute hypoxemic respiratory failure and post-extubation respiratory support for 24 hours post-extubation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 72 hours post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elliott Miller, MD, MS | Contact | 203-737-6390 | elliott.miller@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elliott Miller, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital (CICU or MICU) | Recruiting | New Haven | Connecticut | 06520 | United States |
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Patients with systolic heart failure admitted to the CICU or MICU at Yale New Haven Hospital who require IMV for >24 hours.
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| Patient intolerance to assigned treatment |
Intolerance will be measured as the ability to continue the therapy for the 24 hour treatment period (yes/no). |
| up to 24 hours post-extubation |
| Mean length of stay | Mean length of ICU and hospital stay in days | up to 30 days post-extubation |
| Incidence of ICU mortality | Number of participants with mortality while in ICU | up to ICU discharge (an average of 30 days post-extubation) |
| Hospital mortality | Number of participants with mortality while in hospital | 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 | 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. | on day of extubation |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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