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临床试验/NCT03265938
NCT03265938已完成不适用

Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年9月13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
100
试验地点
1
主要终点
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL

研究概览

简要总结

Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced.

Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy.

Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this patient population, it will reinforce that anesthesiologists need to continue to learn and maintain skills in bronchoscopic intubation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Age> 18 years old
  • Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for head and neck cancer
  • Requiring awake flexible bronchoscopic intubation for surgery
  • Willing and able to provide informed consent

排除标准

  • Emergency Procedure
  • Presence of one or more loose teeth

结局指标

主要结局

Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL

时间窗: Day 1

Number of participants with difficult (Cormack-Lehane grade \>2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL Cormack-Lehane grade in patients with head and neck pathology of the larynx. Cormack-Lehane grade: Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade

时间窗: Day 1

Number of participants with difficult (Cormack-Lehane grade \>2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC Cormack-Lehane grade in patients with head and neck pathology of the larynx. Cormack-Lehane grade: Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified

次要结局

  • Cormack-Lehane Grade Obtained With CMAC D Blade(Day 1)
  • Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL(Day 1)
  • Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade(Day 1)
  • Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL(Day 1)
  • Cormack-Lehane Grade Obtained With Glidescope AVL(Day 1)
  • Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime B Hyman

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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