Impact of Intraoperative High Inspired OXygen Fraction on Pulmonary Function, Surgical Site Infection, Postoperative Nausea and Vomiting in PEDiatric Anesthesia, the OXPED Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
研究概览
简要总结
This study is aiming at assessing the effect of inspired oxygen fraction during general anesthesia on children's lung mechanics and volume. More specifically, the temporal change in end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the perioperative period will be characterized in order to define the the effect of high inspired fraction of oxygen on lung function.
详细描述
High-enriched oxygen fractions (FiO2)are common practice during general anesthesia both to ensure normoxemia despite intrapulmonary shunts and to provide security in case of adverse events. However, high-inspired oxygen fraction may decrease ventilation-perfusion ratios and its benefits are still unproven in children.
The investigators aim at assessing the benefits and potential adverse effects of high-inspired oxygen fraction in two groups of children receiving either 30% FiO2 or 80% FiO2 during maintenance of anesthesia. Nitrogen multiple breath washout technique and forced oscillation technique will be used to measure end-expiratory lung volume (EELV) and airway resistance (Rrs) and respiratory elastance (Xrs) respectively. These measurements will be obtained before the general anesthesia, one hour and one day after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiology (ASA) physical status I and II
- •Body mass index < 30 kg/m2
- •Scheduled for elective surgery in the supine position lasting < 200 min
- •General Anesthesia with tracheal intubation
排除标准
- •Patients hospitalized more than 24 h before the operation
- •History or clinical signs of heart or lung disease
- •Upper respiratory tract infection < 2 weeks prior to surgery
- •Predictable difficult airway
- •History of apnea
- •Abdominal or thoracic surgery
- •Lack of cooperation, language barrier
研究组 & 干预措施
Group High FiO2
Children will receive Fi02 100% during induction of anesthesia until end tidal oxygen concentration (Et 02) of 90% before intubation, anesthesia will be maintained with Fi02 of 80%. Then, shortly before the planned extubation, Fi02 will be increased to 100%.
干预措施: Oxygen (Other)
Group Low FiO2
Children will receive Fi02 80% until Et 02 70% before intubation, anaesthesia will be maintained with Fi02 35%. Then, shortly before the planned extubation, Fi02 will be increased again to 80%.
干预措施: Oxygen (Other)
结局指标
主要结局
Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
时间窗: 24 hours
Measurement of end-expiratory lung volume by nitrogen wash-out technique
Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen
时间窗: 24 hours
Measurement of airway resistance and respiratory system elastance by forced oscillation technique
次要结局
- Respiratory complications(1 month)
- Postoperative nausea and vomiting(24 hours)
研究者
Walid HABRE
Associate Professor
University Hospital, Geneva