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临床试验/NCT07245511
NCT07245511已完成不适用

A Prospective Observational Study Comparing the VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) in Pediatric Patients Aged 5-18 Years Undergoing Tracheal Intubation With Videolaryngoscopy

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家实际入组 416 人开始时间: 2025年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
416
试验地点
2
主要终点
Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children

研究概览

简要总结

This prospective observational study aims to evaluate three scoring systems (VIDIAC (Video Laryngoscopic Intubation and Difficult Airway Classification), PeDiAC (Pediatric Difficult Airway Classification), and the Intubation Difficulty Scale (IDS)).

A total of 450 children undergoing general anesthesia with videolaryngoscopic intubation will be included in the study. Demographic data, intraoperative parameters, and glottic imaging, as well as detailed intubation-related variables such as total intubation time, number of attempts, complications, and subjective intubation ease scores will be recorded.

详细描述

This study is a prospective, observational, single-center study designed to compare three difficult intubation scales (VIDIAC [Video Laryngoscopic Intubation and Difficult Airway Classification], PeDiAC [Pediatric Difficult Airway Classification], and the Intubation Difficulty Scale [IDS]).

A total of 450 children undergoing elective or emergency surgery under general anesthesia at Ankara Bilkent City Hospital will be included in the study. All tracheal intubations will be performed using a C-MAC videolaryngoscope with an endotracheal tube appropriate for the child's age, weight, and surgical indication. No procedures beyond routine clinical practice will be performed, and informed consent will be obtained from parents or legal guardians prior to inclusion in the study.

Data collection will include demographic characteristics (age, gender, weight, height, ASA classification, comorbidities), intraoperative parameters (SpO₂, heart rate), and intubation-related variables: Glottic view graded using the modified Cormack-Lehane classification, time required for glottic visualization, total intubation time, number of attempts, use of adjuncts (stylet, bougie, alternative tubes), complications (desaturation, esophageal intubation, mucosal bleeding, tooth or lip trauma).

This study will evaluate difficult tracheal intubation in pediatric patients aged 5 to 18 years. Three difficult intubations The difficulty of intubation will be rated subjectively (0 = extremely easy, 10 = impossible) by the anesthesiologist performing the intubation and independently by an observer.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • Eligible participants will be pediatric patients aged 5 to 18 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.
  • Pediatric patients between 5 and 18 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 cohort will include pediatric patients aged 5 to 18 years undergoing elective or emergency surgery under general anesthesia who require tracheal intubation. All patients will be intubated using a C-MAC videolaryngoscope. Each intubation will be evaluated using the VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scoring systems.

结局指标

主要结局

Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children

时间窗: Immediately after tracheal intubation

For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children.

A Prospective Observational Study Comparing VIDIAC, PeDiAC, and the Intubation Difficulty Scale (IDS) in Assessing Difficult Intubation in Pediatric Patients Aged 5-18 Years Undergoing Tracheal Intubation with Videolaryngoscopy

时间窗: Immediately after tracheal intubation

For each patient, VIDIAC, PeDiAC, and Intubation Difficulty Scale (IDS) scores will be calculated immediately after tracheal intubation via videolaryngoscopy. These scores will be statistically analyzed to determine the correlation between the number of intubation attempts, intubation time, complications, and subjective intubation ease ratings, in order to identify the scoring system that provides the most reliable assessment of difficult intubation in children.

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
申办方

研究点 (2)

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标识符

NCT 编号
NCT07245511
其他研究编号
VIDIPEDIIDS-25

日期

首次提交
(去年)
首次发布
(10个月前)
主要完成日期
(6个月前)
研究完成日期
(上个月)
最近核实
(12个月前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
是否有结果
否

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