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临床试验/NCT03080896
NCT03080896已完成不适用

Comparison of Video-Laryngoscope Versus a Combination of a Video-Laryngoscope and Disposable Bronchoscope for Predicted Difficult Airway Intubation of Anesthetized Patients for Oral Cavity, Pharynx or Larynx Surgery

University of Louisville2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年4月10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
80
试验地点
2
主要终点
Time to successful intubation

研究概览

简要总结

Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope (aScope III) is a feasible way to facilitate successful intubation in a timely manner, in patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx To test the hypothesis that combination of video-laryngoscope with the fiber-optic bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral cavity, pharyngeal or laryngeal pathologies undergoing surgery

详细描述

Detailed Description:

All subjects consented to this study will require endotracheal intubation. They will be randomly assigned to either one of two groups. The randomization will be stratified on whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization groups are:

  1. Intubation using King Vision video-laryngoscope with the disposable #3 blade and a stylet for placement of the endotracheal tube. This group is considered the "control group".
  2. Intubation using the King Vision video-laryngoscope with the disposable #3 blade and the fiber-optic bronchoscope (aScope III). This group is considered the "interventional group".

When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable blade and a stylet) the procedure sequence is as follows:

  1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse oximetry, capnography, blood pressure and temperature monitoring. Their head will be on an anesthesia pillow. This is all standard procedure.
  2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is standard dosing.
  3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard dosing.
  4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve optimal oxygen saturation
  5. One anesthesiologist will perform the intubation procedure using the King Vision video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the endotracheal tube (ETT).
  6. If the anesthesiologist's first attempt to intubate should fail the next attempt will use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and rightward pressure)
  7. The anesthesiologist may make a total of three attempts to intubate using the control group procedures. Each attempt should be less than 60 seconds and will be aborted if oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between each attempt.
  8. After three failed attempts to intubate the anesthesiologist will use the interventional group method. Two anesthesiologists will be required to perform the intubation using the King Vision video-laryngoscope with a #3 disposable blade and the video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope will be used to guide the endotracheal tube (ETT).
  9. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope III) will be inserted underneath the epiglottis and advance to the carina under direct visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope (aScope III) using the bronchoscope as a guide through the trachea.
  10. Should the first attempt using the interventional method fail the next attempt will use the standard Storz video-laryngoscope and #4 reusable blade along with the video bronchoscope (aScope III)
  11. There may be three attempts using the interventional method. Each attempt should be less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should be aborted. The patient will be pre-oxygenated by mask between each attempt.
  12. After three unsuccessful attempts the patient will be awaken and an "awake" intubation procedure will take place.
  13. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding will be assessed as minimal, moderate, and significant.
  14. Study ends once the patient is intubated and breath sounds confirmed or when it is decided an "awake" intubation is needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • Patient will be eligible for the trial if they:
  • Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy or resection requiring intubation of the trachea
  • Are 18 years or older
  • Sign the approved inform consent

排除标准

  • Patients will be excluded from the study if:
  • Cannot lie down flat without suffering dyspnoea
  • Full stomach
  • Hiatal hernia
  • Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein pump inhibitor and continues to have daily regurgitation
  • Require rapid sequence intubation

结局指标

主要结局

Time to successful intubation

时间窗: From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes

measured in seconds

次要结局

  • Conversion from control group to intervention group(From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes)
  • Number of intubation attempts until successful(From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten minutes)

研究者

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

Rainer Lenhardt

Professor

University of Louisville

研究点 (2)

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