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临床试验/NCT07174050
NCT07174050已完成不适用

Comparison of the King Vision Channeled Videolaryngoscope and Conventional Laryngoscopy for Endotracheal Intubation Time in Novice Users: A Prospective, Randomised Controlled Trial

Hitit University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Time to successful endotracheal intubation (seconds)

研究概览

简要总结

This study evaluated two different devices used for placing a breathing tube (endotracheal intubation) in adult patients undergoing elective surgery. The aim was to compare the King Vision videolaryngoscope, which has a camera and a guiding channel for the tube, with the traditional Macintosh laryngoscope, which allows doctors to look directly at the vocal cords. The study focused on how long it takes to successfully insert the tube, the need for additional maneuvers during the procedure, and the overall success rate of first attempts. The procedures were performed by novice operators under supervision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years old) scheduled for elective surgery under general anesthesia requiring orotracheal intubation
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Mallampati airway classification I-II
  • Written informed consent obtained from the patient

排除标准

  • Predicted or known difficult airway: Mallampati III-IV, inter-incisor distance <2.5 cm, thyromental distance <6 cm, limited cervical spine mobility
  • History of difficult intubation or need for awake/rapid-sequence intubation
  • Upper airway pathology (tumour, trauma, infection), limited mouth opening, or craniofacial anomalies
  • Emergency surgery, high aspiration risk, or full stomach
  • Severe cardiopulmonary instability (e.g., shock, severe hypoxaemia)
  • Pregnancy or breastfeeding
  • BMI >35 kg/m² (if your protocol excludes obesity; remove if not applicable)
  • Participation refusal or inability to consent

结局指标

主要结局

Time to successful endotracheal intubation (seconds)

时间窗: During intubation (intraoperative period, approximately 1-2 minutes)

Measured from insertion of the laryngoscope blade between the patient's incisors until removal of the blade after correct placement of the endotracheal tube, confirmed by capnography.

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat KAYKAC

M.D.

Izmir City Hospital

研究点 (1)

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