Lateral Positioning During the Anesthesia Emergence After Ambulatory Adenotonsillectomy in Children on Postoperative Respiratory Adverse Events: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- the occurrence of postoperative respiratory adverse events (PRAEs)
研究概览
简要总结
The postoperative recovery period following general anesthesia has been associated with a 30%-50% incidence of postoperative respiratory adverse events (PRAEs) in pediatric populations, including laryngospasm, airway obstruction, and hypoxemia. Despite the limited effects of existing pharmacological and operative interventions, positional optimization (e.g., lateral or semirecumbent position) may play a potential role by decreasing airway resistance and improving oxygenation. However, evidence-based evidence for its use in pediatric populations is still lacking, necessitating the urgent need for randomized controlled trials.
详细描述
This study is a multi-center, prospective, RCT conducted at four tertiary hospitals in China. It will be planned to include 350 subjects who meet the inclusion criteria and will be randomly divided into the lateral position and supine position group in a 1:1 ratio by the method of block group randomization stratified by centers. In the supine position group, the children will be extubated at the end of the procedure and observed in the decubitus position until the patient's Aldrete score was >9 and they left the PACU, whereas in the lateral position group, the children will be extubated and observed in the head-up 30° lateral position. The primary outcome is the incidence of PRAEs. Secondary outcomes included frequency of PRAE, number of airway devices used during the postoperative recovery period, time to tracheal extubation, length of stay in the recovery room, and incidence of PRAE at 24 hours and 7 days. postoperatively. Safety outcomes include the incidence of peripheral IV access dislodgement, monitoring device detachment rate, and patient falls rate. Exploratory outcomes comprise pain levels (assessed via the FLACC scale), agitation scores (PAED scale), sedation scores (Ramsay scale), and PONV scores, all evaluated at postoperative extubation and PACU discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Given the intervention's nature, full blinding was impossible; only postoperative data collectors and analysts were blinded. To minimize potential bias, we plan to maintain blinding among participants, anesthesiologists and surgeons in the operating room, the data collectors who conduct inpatient and telephone follow-up visits and data analysts. However, blinding could not be preserved for investigators, post-anesthesia care unit (PACU) outcome measure recorders, care providers in the PACU.
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 1-6 years old without gender limit.
- •Scheduled for an ambulatory adenotonsillectomy under general anesthesia.
- •American Society of Anesthesiologists (ASA) classification grade I or II.
- •Informed consent obtained from the patients' parents or legal guardians, who have expressed willingness to cooperate.
排除标准
- •Presence of concomitant cardiac or pulmonary dysfunction or other significant systemic comorbidities.
- •History of difficult airway management or congenital/acquired structural anomalies of the airway.
- •Active respiratory tract infection within 30 days preceding surgery.
- •Preoperative neurological disorders or developmental abnormalities.
- •Intraoperative occurrence of major complications necessitating deviation from the planned anesthesia protocol or surgical procedure.
研究组 & 干预措施
lateral position group
In the experimental group, the children will be placed in a head-up 30° lateral position for tracheal extubation and observation at the end of the procedure.
干预措施: lateral postion (Procedure)
the supine position group
In the control group, the patients will be placed into a supine position for extubation and observation at the end of the procedure.
干预措施: supine position (Procedure)
结局指标
主要结局
the occurrence of postoperative respiratory adverse events (PRAEs)
时间窗: during PACU
PRAEs include a diverse array of respiratory complications, including laryngospasm, bronchospasm, apnea, airway obstruction, stridor, cough/choking, hypoxemia.
次要结局
- The PRAEs at 7 days after surgery(at 7 days postoperatively)
- Tracheal extubation time(during PACU)
- Frequency of PRAEs(during PACU)
- Number of Emergency Airway Interventions(during PACU)
- PACU stay duration(during PACU)
- Length of hospital stay(postoperative day 1)
- The PRAEs at 24 hours after surgery(at 24 hours postoperatively)
研究者
Peng Liang，MD
Professor
Sichuan University