High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery
研究概览
简要总结
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
详细描述
This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric patients post-cardiac surgery at the Cipto Mangunkusumo National General Hospital. Additionally, this study seeks to identify factors influencing extubation failure in high-risk patient populations, compare CICU length of stay, sedation usage and COMFORT scale between patients receiving HFNC and those receiving NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Due to the visible and functional differences between High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV), masking of participants, care providers, investigators, and outcomes assessors is not feasible.
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 18 years of age.
- •Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital
- •Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation >48 hours).
- •Patients who pass the extubation readiness test and spontaneous breathing trial.
排除标准
- •Diaphragmatic paralysis.
- •Decreased consciousness.
- •Neuromuscular disease.
- •Pneumothorax without drainage.
- •Airway obstruction.
- •Patients with a tracheostomy.
- •Unplanned extubation.
- •Patient received PEEP (Positive End-Expiratory Pressure) >7 prior to extubation
结局指标
主要结局
Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery
时间窗: 72 hours post-extubation
Participants who require reintubation due to respiratory failure, clinical deterioration, or complications related to respiratory support will be recorded. This outcome will be compared between the HFNC and NIV groups to assess extubation success.
次要结局
- Length of Stay in the Cardiac Intensive Care Unit (CICU)(1 month)
- Change in COMFORT Scale Scores Post-Extubation(Up to 48 hours post-extubation)
- Total Duration of Sedation Post-Extubation(Up to 72 hours post-extubation)
- Total Dosage of Sedation Post-Extubation(Up to 72 hours post-extubation)
研究者
Yogi Prawira
Head of Pediatric Emergency and Intensive Care Divison
Indonesia University