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临床试验/NCT02705794
NCT02705794已完成不适用

Clinical Trial of Comparative Evaluation of Modified Mallampati Score and Modified Mallampati Score Along With Thyromental Distance, Anatomical Abnormalities and Cervical Mobility in Predicting Difficult Airway

Government Medical College, Haldwani0 个研究点目标入组 200 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
主要终点
Difficulty of intubation

研究概览

简要总结

The study title "Clinical trial of comparative evaluation of the Modified Mallampati Score and Modified Mallampati Score along with Thyromental distance, Anatomical abnormality, and Cervical mobility (M-TAC) in Predicting Difficult Airway " was undertaken to evaluate prediction of difficult airway by comparing preoperative airway evaluation tests.

Mallampati classification is the most used screening test for detection of difficult intubation it is a classification of oropharyngeal view. Other tests include sternomental distance, thyromental distance, Wilson risk sum score, upper lip bite test, protrusion of mandible, tooth morphology, head extension, mouth opening, body mass index, 3-3-2 rule and ultrasonography of neck soft tissue. We studied 200 adult ASA I & II patients of either sex, aged between 18-60 yrs undergoing elective surgery receiving general anesthesia.

Modified mallampati classification had four grades & each grade was given a score, similarly thyromental distance (TMD), anatomical abnormality (AA) & cervical mobility (CM) was classified into three grades & each grade was given a score. For M-TAC individual scores were added.

详细描述

The term 'airway' refers to the upper airway which may be defined as the extra-pulmonary air passage, consisting of the nasal and oral cavities, pharynx, larynx, trachea and large bronchi.

The most commonly applied methods of oxygenation is ventilation through a tracheal tube, a laryngeal mask, or a face mask. Problems with tracheal intubation remain the major cause of death and disability due to anaesthesia in analyses of records of the United Kingdom medical defence societies and in the American Society of Anaesthesiologists closed claims database.

'Difficult airway' is one in which there is a problem in establishing or maintaining gas exchange via a mask, an artificial airway or both. Prediction of difficult airway management remains a pivotal challenge for anaesthesiologists because accurate prediction gets altered the potentially dangerous unanticipated airway to an anticipated difficult airway with, predominantly, ample time for proper preparation. This is helpful in reducing potential complications by the allocation of experienced personnel and by using relevant equipment and well planned strategies .

However rare, in spite of this, occurrence of difficult airway management still occurs and it prompts to increase the risk of morbidity and mortality - especially when not anticipated. Unanticipated difficulty in intubation in patients for elective surgical procedures can occur in 1.5 to 13 percent cases with none of the above mentioned abnormalities resulting in both morbidity and mortality.

Several pre-operative risk factors for assessing airway difficulties have been identified, yet none have convincing diagnostic accuracy when using in isolation. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • -Adult patients aged 18-60 years.
  • American Society of Anesthesiologists (ASA) I or II, scheduled for elective surgeries under general anaesthesia requiring endotracheal intubation

排除标准

  • - Patient refusal
  • ASA grade III and IV
  • Cervical spine disorder
  • Obstructive airway tumor
  • Edentulous patients /Irregular dentition
  • past history of difficult laryngoscopy and intubation.
  • trauma to the airways or to the cranial, cervical, and facial regions
  • history of previous surgery, burns to airways & adjacent structures
  • Mouth opening<3 cm
  • Age <18 years & > 60 years

结局指标

主要结局

Difficulty of intubation

时间窗: 10 minutes

Difficulty of intubation is assessed by modified Cormack and Lehane grading. Modified Cormack and Lehane and grading consists of 4 grades. Grade 3 and 4 is considered as difficulty intubation.

次要结局

未报告次要终点

研究者

发起方
Government Medical College, Haldwani
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bikramjit Das

Assistant Professor

Government Medical College, Haldwani

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