A Prospective Randomized Controlled Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
Extubation to HFNC
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.
干预措施: Airvo 3 (Device)
Control: Extubation to NIV for 24hrs post-extubation.
The NIV will be immediately initiated after planned extubation using specific, predetermined ventilator settings for 24 hours.
干预措施: Airvo 3 (Device)
结局指标
主要结局
Incidence of participants with reintubation or respiratory failure within 72 hours post-extubation
时间窗: up to 72 hours post-extubation
Number of participants with reintubation or respiratory failure within 72 hours post-extubation
次要结局
- Incidence of Reintubation or respiratory failure(48 hours, 7 days, and up to ICU discharge (an average of 30 days post-extubation))
- Patient intolerance to assigned treatment(up to 24 hours post-extubation)
- Mean length of stay(up to 30 days post-extubation)
- Incidence of ICU mortality(up to ICU discharge (an average of 30 days post-extubation))
- Hospital mortality(48 hours, 72 hours, 7 days, and hospital discharge (an average of 30 days post-extubation))
- Time to reintubation(Immediately post-extubation up to 30 days post-extubation)
- Respiratory rate-oxygenation (ROX) index and vector(on day of extubation)
研究者
Elliott Miller
Assistant Professor of Medicine
Yale University