Prospective Assessment of Perioperative Respiratory Adverse Events in Pediatric Patients Undergoing Cleft Lip and Palate Surgery: Predictive Risk Factors and the Role of Clinical Airway Scores
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Incidence of Perioperative Respiratory Adverse Events (PRAEs)
研究概览
简要总结
Cleft lip and palate surgeries present unique anesthetic challenges due to shared airway access with the surgical field, frequent anatomical abnormalities, and a predominantly infant and toddler population. These factors substantially increase the risk of perioperative respiratory adverse events (PRAEs), including laryngospasm, bronchospasm, desaturation, post-extubation stridor, and unanticipated re-intubation.
This prospective single-center observational cohort study aims to determine the true incidence of PRAEs in pediatric patients undergoing elective cleft lip and/or palate repair under general anesthesia, and to identify independent predictive risk factors using standardized airway assessment tools including the Han Mask Ventilation Score and the Intubation Difficulty Score (IDS). No interventions beyond routine clinical practice will be applied. All airway management decisions will remain at the discretion of the attending anesthesiologist.
详细描述
Cleft lip and palate are among the most common congenital craniofacial anomalies.
The surgical population predominantly consists of infants and young children who may present with associated syndromes, micrognathia, retrognathia, or obstructive sleep apnea - all of which contribute to difficult mask ventilation and difficult intubation. Sharing the airway with the surgical team and the use of the Dingman retractor further increase the risk of airway compromise during emergence and extubation. Published data on PRAE incidence in this population are largely retrospective and heterogeneous, and no adequately powered prospective study has systematically evaluated predictive risk factors using validated scoring systems.
Study Design:
Prospective, single-center, observational cohort study conducted at Marmara University Pendik Training and Research Hospital, Istanbul, Turkey. No interventions beyond established routine anesthesia protocols will be performed. Parental written informed consent will be obtained prior to enrollment.
Anesthetic Protocol:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-3 years (infants and toddlers)
- •Scheduled for elective cleft lip and/or palate repair surgery
- •General anesthesia planned
- •Written parental/guardian informed consent obtained
排除标准
- •Pre-existing respiratory failure or active tracheostomy
- •Emergency surgical procedures
- •Inability to obtain parental/guardian consent
研究组 & 干预措施
Cleft Lip and/or Palate Surgery Cohort
Pediatric patients aged 0-3 years undergoing elective cleft lip and/or palate repair under general anesthesia. All subjects are managed per routine anesthesia protocol. Perioperative airway events and predictive clinical variables are prospectively recorded from induction through PACU discharge.
干预措施: Standard General Anesthesia per Institutional Protocol (Other)
结局指标
主要结局
Incidence of Perioperative Respiratory Adverse Events (PRAEs)
时间窗: first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.
Composite outcome defined as the occurrence of at least one of the following: laryngospasm, bronchospasm, post-extubation stridor, oxygen desaturation lasting \>10 seconds (SpO₂ \<90%), or unplanned re-intubation, occurring at any point from induction through PACU discharge
次要结局
- Independent Predictors of PRAE - Odds Ratios(first 24 hours from anesthesia induction. assessed up to 24 hours postoperatively.From anesthesia induction to discharge from the hospital.)
- Intubation Difficulty Score (IDS)(Intraoperative)
- Han Mask Ventilation Score(Intraoperative, at time of mask ventilation)
- Minimum SpO₂ During Intubation(Lowest pulse oximetry value recorded during laryngoscopy and intubation attempts.)
- Minimum SpO₂ During Extubation(Lowest pulse oximetry value recorded during and immediately after extubation.)
- Postoperative ICU Admission Rate(Within 24 hours of surgery)
- Postoperative Hospital Length of Stay(From surgery to hospital discharge, assessed up to 30 days)
研究者
dilara gocmen
assist prof
Marmara University Pendik Training and Research Hospital