The Effects of Different Prone Positioning Angles on Cardiopulmonary Function in Children After Congenital Heart Disease Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Lung Compliance
研究概览
简要总结
The goal of this randomized controlled trial is to learn if different head-elevated prone positioning angles can optimize cardiopulmonary function and enteral nutrition tolerance in infants and children after congenital heart disease (CHD) surgery. The main questions it aims to answer are:
- Do specific prone positioning angles (10°, 30°, or 45°) lead to better improvements in cardiopulmonary recovery, specifically regarding oxygenation, lung compliance, airway resistance, and hemodynamic stability?
- Does increasing the elevation angle improve the tolerance of enteral nutrition (tube feeding) while maintaining patient safety?
Researchers will compare three different head-of-bed elevation angles (10°, 30°, and 45°) to see if a specific angle offers superior heart and lung support and nutritional benefits during the early postoperative period.
Participants will:
- Be randomly assigned to one of three groups: 10°, 30°, or 45° head-elevated prone position.
- Maintain the assigned prone position for at least 12 hours daily.
- Undergo monitoring of cardiopulmonary indicators (including oxygen levels, ventilator parameters, blood pressure, and central venous pressure) and digestive function (gastric residual volume) at scheduled intervals (0, 4, 6, and 12 hours).
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
- Single (Outcomes Assessor)
盲法说明
people processing the numbers (statisticians) and recording the numbers (data collectors)
入排标准
- 年龄范围
- 0 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital Heart Disease (CHD) confirmed by echocardiography with surgery performed.
- •RACHS-1 score ≥
- •Postoperative acute hypoxemia, defined as PaO2/FiO2 ≤ 100 mmHg with bilateral infiltrates.
- •Receiving invasive mechanical ventilation.
- •Nasogastric or nasoenteric tube in place.
- •Hemodynamic stability for ≥ 72 hours (inotropic score ≤ 25).
排除标准
- •Cardiac arrest or age-specific bradycardia (> 20% below normal).
- •Active bleeding.
- •Significant pneumothorax.
- •Delayed sternal closure.
- •Transfer to another facility or death before completing the protocol.
- •Withdrawal of consent by legal guardians.
结局指标
主要结局
Lung Compliance
时间窗: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
Oxygenation Index (OI)
时间窗: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
The Oxygenation Index is a measure used to assess the severity of hypoxic respiratory failure and lung function recovery. It is calculated using the formula: OI = (FiO2 × Mean Airway Pressure × 100) / PaO2. Arterial blood gases (PaO2) are obtained from arterial lines, and FiO2 and mean airway pressure are recorded from the ventilator. Lower scores indicate better oxygenation status.
Airway Resistance
时间窗: Baseline (0 hours), 4 hours, and 6 hours after initiation of prone positioning.
Airway resistance is measured by the mechanical ventilator to assess the resistance of the respiratory tract to airflow. Lower values indicate better airway patency and less obstruction. Unit: cmH2O/L/s.
次要结局
- Gastric Residual Volume (GRV)(Baseline (0 hours), 6 hours, and 12 hours after initiation of prone positioning.)