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Идёт набор NCT07245511

Comparison of VIDIAC, PeDiAC and Intubation Difficulty Scale in Pediatric Patients Undergoing Videolaryngoscopic Intubation

— Наблюдательное Videolaryngoscopy Intubation Difficulty Scale Vidiac Score Difficult Airway Intubation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Videolaryngoscopy, Intubation Difficulty Scale, Vidiac Score, Difficult Airway Intubation. Базовые параметры: 5 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Comparison of VIDIAC, PeDiAC, and IDS Scores in the Evaluation of Difficult Intubation in Children [Срок оценки: Immediately after tracheal intubation]
  • 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 [Срок оценки: Immediately after tracheal intubation]

Критерии участия

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.

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Bilkent City Hospital, Department Of Anesthesiology and Reanimation — Ankara

Идентификаторы

NCT: NCT07245511 · VIDIPEDIIDS-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗