Association Between Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Adverse Events in Children Under Three Years of Age
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
- Perioperative respiratory adverse events (PRAE)
研究概览
简要总结
This study aims to better understand postoperative respiratory adverse events that may occur in some children under three years of age undergoing airway management during surgery. As part of the study, ultrasonographic measurements of a portion of the upper airway will be performed during surgery using a non-invasive ultrasound device. These measurements will be evaluated in relation to perioperative respiratory outcomes. The results of this study may contribute to improved understanding of airway-related factors associated with postoperative respiratory safety in young children.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0 to 35 months
- •Scheduled for elective surgery under general anesthesia
- •Planned airway management with a laryngeal mask airway
- •Ability to perform intraoperative ultrasonographic subglottic airway measurements
- •Written informed consent obtained from a parent or legal guardian
排除标准
- •Known congenital or acquired airway anomalies
- •Craniofacial anomalies
- •Emergency surgical procedures
- •Planned tracheal intubation instead of laryngeal mask airway
- •Inability to obtain adequate ultrasonographic subglottic airway measurements
研究组 & 干预措施
Pediatric patients under three years of age
This cohort includes children under three years of age undergoing elective surgery. As part of routine perioperative care, ultrasonographic measurements of the subglottic airway are performed during surgery. Participants are followed postoperatively for the occurrence of respiratory-related adverse events.
干预措施: Ultrasonographic subglottic airway measurement (Other)
结局指标
主要结局
Perioperative respiratory adverse events (PRAE)
时间窗: immediately after the surgery
The occurrence of clinically significant perioperative respiratory adverse events, defined as moderate to severe stridor and/or laryngospasm requiring clinical intervention, including positive pressur
次要结局
- Ultrasonographic subglottic airway dimensions and area(During surgery)
研究者
Gürcan Güler
Principal Investigator
Bursa Sevket Yilmaz Training and Research Hospital