跳至主要内容
临床试验/NCT04844723
NCT04844723已完成不适用

Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 809 人开始时间: 2021年4月12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
809
试验地点
1
主要终点
Difficult videolaryngoscopic intubation

研究概览

简要总结

The study's primary aim is to develop and validate a multivariable diagnostic model for the prediction of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification.

详细描述

Difficult tracheal intubation is one of the major reasons for anesthesia-related adverse events. Videolaryngoscopy has become an important part of the anesthesiology standard of care for difficult airway management in the past decades. This is especially relevant in children, as their airway anatomy differs greatly from adults because they are likely incapable of tolerating brief apneic episodes. Still, medical preconditions and procedural and technical factors related to difficult videolaryngoscopy have not been broadly investigated and not fully been understood.

The primary aim of the PeDiAC study is to develop and validate a multivariable diagnostic model for the classification of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. Study planning and conduction are in accordance with the TRIPOD 'Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis' statement. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification, which is the current clinical standard for assessing intubation via direct laryngoscopy. We conduct a prospective observational study that will include approximately 800 pediatric patients within one year scheduling for tracheal intubation. Patients with age below 18 years will be considered to be eligible for inclusion. Procedural and surgical data, as well as medical preconditions, will be assessed systematically. After tracheal intubation, performed by the responsible anesthetist, the intubation process will be rated by the responsible anesthetist and an additional independent observer, and detailed information regarding procedural and technical factors related to videolaryngoscopy will be documented. All sampled independent variables will be considered to be potential candidate predictors for the multivariable regression model.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
  • Informed consent obtained
  • Age < 18 years

排除标准

  • Anesthetist prefers conventional laryngoscopy
  • Indication for intubation via a bronchoscope or awake intubation

结局指标

主要结局

Difficult videolaryngoscopic intubation

时间窗: 1 hour

Rating by the responsible anesthetist

次要结局

  • Hypercapnia(1 hour)
  • Change of airway technique(1 hour)
  • Number of attempts(1 hour)
  • Post-intubation diagnosis of 'difficult intubation'(1 hour)
  • Airway-related adverse events(1 hour)
  • Difficult bag-mask ventilation(1 hour)
  • Lowest oxygen saturation(1 hour)
  • Post-intubation recommendation for an anesthesia alert cart(1 hour)
  • First pass success rate(1 hour)
  • Overall success rate with the first-choice technique(1 hour)
  • Intubation difficulty, ease of intubation and quality of visualisation(1 hour)
  • Best glottic view(1 hour)
  • Time to best view(1 hour)
  • Intubation time(1 hour)
  • Post-intubation recommendation for an intubation method(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验