跳至主要内容
临床试验/NCT03310866
NCT03310866已完成不适用

Macintosh Laryngoscope Assisted Flexible Fiber Optic Endotracheal Intubation Versus Classic Fiber Optic Laryngoscope Alone Endotracheal Intubation for Modified Mallampati III&IV Patients : A Prospective Randomized Controlled Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月15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
2
主要终点
intubation time

研究概览

简要总结

During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III&VI Modified Mallampati .

详细描述

Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.

All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with Modified Mallampati (NT-MMT) airway score III,VI
  • American Society of Anaesthesiologists (ASA) physical class I-III
  • Scheduled for elective cancer surgery under general anesthesia

排除标准

  • Modified Mallampati I,II Airway scored patients.
  • History of upper airway surgery.
  • Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.
  • Patients with a history of significant cardiac and pulmonary diseases,
  • Obesity with BMI >40,
  • Epilepsy, pregnancy, mental disease, neurological psychological disorders.
  • Communication barrier.

结局指标

主要结局

intubation time

时间窗: during intubation

time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds.

次要结局

  • mean heart rate (HR)(during intubation till 5 minutes after intubation)
  • lower jaw relaxation(during intubation)
  • Neck movements(during intubation and cuff inflation)
  • Vocal cord position(during intubation)
  • Cough(during intubation and cuff inflation)
  • 1st trial success rate(during intubation)
  • the number of trails(during intubation)
  • mean arterial Blood pressure (MBP)(during intubation till 5 minutes after intubation)
  • desaturation (SpO2)(during intubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Macintosh Laryngoscope Assisted Fiberoptic Intubation | 临床试验