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临床试验/NCT02679027
NCT02679027已完成不适用

New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements

Trakya University0 个研究点目标入组 223 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
223
主要终点
Intubation difficulty scale

研究概览

简要总结

Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.

Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.

To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Undergoing abdominal surgery with general anesthesia
  • •Able to sit

排除标准

  • •Enable to sit,
  • •Patients had head or neck surgery,
  • •Patients with unstable cardiological and respiratory hemodynamic symptoms,
  • •Dental prosthesis

研究组 & 干预措施

Easy intubation

Active Comparator

Intubation difficulty score <5

干预措施: Protrude tongue maximally and upward (PTMU) (Other)

Easy intubation

Active Comparator

Intubation difficulty score <5

干预措施: Protrude tongue maximally and downward (PTMD) (Other)

Difficult intubation

Active Comparator

Intubation difficulty score >5

干预措施: Protrude tongue maximally and upward (PTMU) (Other)

Difficult intubation

Active Comparator

Intubation difficulty score >5

干预措施: Protrude tongue maximally and downward (PTMD) (Other)

结局指标

主要结局

Intubation difficulty scale

时间窗: 2 days

Intubation difficulty scale score includes 7 variables for difficult intubation. N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point). A score of 0-4 defines easy intubation and an IDS score ≥5 defines difficult intubation

次要结局

未报告次要终点

研究者

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

Alkin Colak

Associate professor

Trakya University

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