Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia and Associations With Postoperative Pulmonary Complications - a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 4
- 主要终点
- Incidence of postoperative pulmonary complications
研究概览
简要总结
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.
详细描述
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.
Objective
The aims of this study are to:
- determine the incidence of PPCs in pediatric patients;
- describe the practice of ventilatory support in children undergoing general anesthesia;
- describe geo-economic differences/variations in ventilatory support and development of PPCs in children undergoing general anesthesia;
- identify potentially modifiable factors that have independent associations with development of PPCs, hospital length of stay and pediatric intensive care unit (PICU) admittance; and
- develop a risk score for the development of PPCs comparable to the ARISCAT score.
Study design Multicenter international observational cohort study. Study population Patients ≤16 years of age undergoing invasive ventilation for general anesthesia in the operating room.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≤ 16 years;
- •undergoing general anesthesia
- •airway management with tube or LMA; and
- •connected to mechanical ventilator . minimum duration of procedure: 15 minutes
排除标准
- •patients undergoing surgical procedures involving extra-corporal circulation;
- •patients receiving ventilation with high frequency jet ventilation or high frequency oscillatory ventilation;
- •sedation without airway management in the form of a endotracheal tube or a supraglottic airway device; and
- •(rigid) bronchoscopic procedures with maintenance of spontaneous ventilation.
结局指标
主要结局
Incidence of postoperative pulmonary complications
时间窗: follow-up up to day 5 postoperative
incidence of postoperative pulmonary complications (PPCs) in the first five postoperative days. Definition of postoperative pulmonary complications: • Invasive mechanical ventilation after discharge from the operating room. * respiratory failure defined as: PaO2 \< 8 kPa or SpO2\< 90% despite oxygen therapy, with a need for non-invasive ventilation (NIV) * unplanned oxygen therapy, including humidified high flow nasal oxygen (oxygen administered due to PaO2\< 8 kPa or SpO2\< 90% in room air * need for bronchodilators postoperatively in the PACU or at the ward; * pneumonia; * ARDS; * pneumothorax.
次要结局
- Respiratory rate(15 minutes after incision)
- Compliance (Crs)(15 minutes after incision)
- Driving pressure(15 mintues after incision)
- Intraoperative complications(during surgery)
- Inspiratory fraction of oxygen (FiO2)(15 minutes after incision)
- Saturation (SpO2)(15 mintues after incision)
- end-tidal carbondioxide (etCO2)(15 minutes after incision)
- postoperative end-expiratory pressure (PEEP)(15 minutes after incision)
- Peak inspiratory pressure or plateau pressure(15 minutes after incision)
- Mechanical power(15 minutes after incision)
- Admittance to PICU or neonatal intensive care unit (NICU)(follow-up up to day 5 postoperative)
- type of ventilation mode(15 minutes after incision)
- Tidal volume (Vt)(15 minutes after incision)
- Level of pressure support above PEEP(15 minutes after incision)
- I:E ratio(15 minutes after incision)
- Length of hospital stay(follow-up up to day 5 postoperative)
研究者
Jorinde Polderman
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)