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临床试验/NCT07141485
NCT07141485已完成不适用

Comparison of the PeDiAC Score and Intubation Difficulty Scale in Pediatric Patients Aged 0-5 Years Undergoing Tracheal Intubation With Videolaryngoscopy

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
430
试验地点
1
主要终点
Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years

研究概览

简要总结

This prospective observational study aims to compare the effectiveness of the Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS) in evaluating difficult tracheal intubation in pediatric patients aged 0 to 5 years. Patients undergoing general anesthesia with videolaryngoscopic intubation will be assessed using both scoring systems. The study seeks to determine which system more accurately reflects the difficulty of intubation and serves as a better guide for future anesthetic management, ultimately contributing to improved patient safety.

详细描述

This prospective observational study aims to compare the effectiveness of two scoring systems-Paediatric Videolaryngoscopic Intubation and Difficult Airway Classification (PeDiAC) and the Intubation Difficulty Scale (IDS)-in assessing the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Pediatric patients undergoing elective or emergency surgery under general anesthesia will be included in the study. All intubations will be performed using a C-MAC videolaryngoscope.

Demographic data such as age, sex, weight, height, ASA physical status, and comorbidities will be recorded. Intraoperative monitoring parameters including peripheral oxygen saturation (SpO₂) and heart rate will also be documented. During intubation, the glottic view will be graded according to the Modified Cormack-Lehane classification.

Additional variables-including the time required to achieve optimal glottic visualization, total intubation time (from insertion of the device to cuff inflation), number of intubation attempts, and any complications (e.g., desaturation, mucosal bleeding)-will be noted.

Following intubation, both the intubating anesthesiologist and an independent observer will assign a subjective difficulty score using a visual analog scale ranging from 0 (extremely easy) to 10 (impossible). Subsequently, PeDiAC and IDS scores will be calculated for each case.

The primary objective is to determine which of the two scoring systems more accurately reflects the actual difficulty of tracheal intubation in this age group and to identify the one that may better guide future airway management strategies-ultimately aiming to improve safety and clinical outcomes in pediatric anesthesia.

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
0 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Eligible participants will be pediatric patients aged 0 to 5 years who are undergoing general anesthesia for any surgical procedure. All included patients must undergo tracheal intubation using a videolaryngoscope (C-MAC). Patients must have an ASA physical status classification of I to IV and written informed consent must be obtained from a parent or legal guardian prior to participation.
  • Inclusion Criteria:
  • Pediatric patients between 0 and 5 years of age
  • Undergoing general anesthesia for any type of surgical procedure
  • ASA physical status classification I to IV
  • Written informed consent obtained from parents or legal guardians

排除标准

  • Patients undergoing awake fiberoptic intubation
  • History of tracheal resection or reconstruction surgery
  • Refusal to participate or absence of informed consent

研究组 & 干预措施

Pediatric Patients Undergoing Videolaryngoscopic Intubation

This group includes pediatric patients aged 0-5 years undergoing elective or emergency surgery under general anesthesia with videolaryngoscopic intubation. All patients will be evaluated for intubation difficulty using both the PeDiAC and the Intubation Difficulty Scale (IDS).

结局指标

主要结局

Comparison of PeDiAC Score and IDS Score for Predicting Difficult Intubation in Children Aged 0-5 Years

时间窗: Immediately after tracheal intubation

This outcome measure evaluates the effectiveness of two scoring systems-PeDiAC and Intubation Difficulty Scale (IDS)-in reflecting the difficulty of tracheal intubation in pediatric patients aged 0 to 5 years. Both scores will be calculated for each patient immediately after intubation. The correlation between each score and the actual intubation experience will be statistically analyzed to determine which scoring system better predicts intubation difficulty.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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