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临床试验/NCT03613103
NCT03613103已完成不适用

Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial

Universidad de Antioquia2 个研究点 分布在 1 个国家目标入组 716 人开始时间: 2018年10月1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
716
试验地点
2
主要终点
Number of patients with an airway injury

研究概览

简要总结

Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. However, difficulties with the tracheal intubation arise the need to use alternative laryngoscopes that use digital or fiberoptic technology, to improve the larynx visibility. Among these devices, highly curved blade videolaryngoscope uses a curved blade to retract the soft tissues of floor of the mouth and transmits a video image to a screen, achieving better larynx visibility. Also, the decrease of the force in the soft tissues with videolaryngoscope could reduce airway injures.

Objectives Our primary objective is to assess whether use of videolaryngoscopy using highly curved blades for tracheal intubation in adults requiring general anesthesia reduces risk of airways injuries compared with Macintosh direct laryngoscopy. Our secondary aim is to assess postoperative satisfaction of the patients, successful intubation at the first attempt, successful global intubation, degree of larynx visibility according to classification Cormack - Lehane and time taken to perform intubation in videolaryngoscopy vs direct laryngoscopy. Finally, we assess the risk of presenting serious adverse event with the use of videolaryngoscopy compared with Macintosh laryngoscopy in hypoxemia, bradycardia and heart arrest.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants will be assigned at the time of anesthetic induction in the surgery room. The allocation to the direct laryngoscopy group and the video laryngoscopy will be 1: 1 randomly using permuted blocks, generated by a computer operated by an external assistant to the investigation. The size of the blocks will be between 4, 6, and 8.

A person external to the research group will be responsible for concealment of allocation through opaque and sealed envelopes, listed sequentially.

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

  • Over 18 years of age.
  • Scheduled for a procedure or surgery that requires general anesthesia that requires orotracheal intubation.
  • Scheduled for non-cardiac surgery.
  • Elective surgery.

排除标准

  • Women in pregnancy.
  • Patient refuses to participate in the study before surgery.
  • Patients with predictors of anticipated difficult airway.
  • Head and neck surgery.
  • Go to Intensive Care Unit with endotracheal intubation.

结局指标

主要结局

Number of patients with an airway injury

时间窗: 24 hours

Airway injury will be a composite outcome as follow: Injury in the oral cavity or injury in the laryngopharynx. These injuries will be evaluated using a digital camera of the oral cavity (fiber optical camera) in the immediate POP. A patient will be considered positive for the outcome If he/she has at least one of the following findings: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma in labial, jugal, gingival, lingual mucosa, hard and soft palate; Dental pieces injury: partial and / or total loss of the integrity of the dental piece; Larynx lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding of pharyngeal laryngeal mucosa.

次要结局

  • Successful intubation at the first attempt(Immediate postoperative)
  • Hypoxemia during induction and intubation(Immediate postoperative)
  • Global of Successful Intubation(Immediate postoperative)
  • Cormack-lehane visualization(Immediate postoperative)
  • Time to achieve orotracheal intubation(Immediate postoperative)
  • Post-anesthetic satisfaction(Immediate postoperative)
  • Bradycardia during induction and intubation(Immediate postoperative)
  • Cardiac Arrest(Immediate postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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