Noninvasive Ventilation Versus High-Flow Nasal Cannula After Extubation in High-Risk ICU Patients (NIV-HFNC)
Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Qalyubia Governorate
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Banhā、Qalyubia Governorate、埃及、13511
- Benha University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
inclusion criteria
- Age ≥18 years.
- Received invasive mechanical ventilation for at least 24 hours.
- Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
- High risk of extubation failure, defined by the presence of at least four of the following risk factors:
Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Exclusion Criteria:
- Age <18 years.
- Presence of a tracheostomy.
- Accidental extubation.
- Self-extubation.
- Contraindication to noninvasive ventilation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NIV
Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.
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NIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG & Co. KGaA, Lübeck, Germany).
Ventilator settings were adjusted to achieve a respiratory rate <26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35).
Sedation was not permitted.
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有源比较器：HFNC
Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.
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HFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C. In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reintubation Rate
大体时间：7 days
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Proportion of patients requiring reintubation following planned extubation.
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7 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Reintubation
大体时间：7 days
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Time elapsed from extubation to reintubation among patients requiring reintubation.
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7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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