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临床试验/CTRI/2022/11/047478
CTRI/2022/11/047478已完成不适用

Thyromental height as a predictor of difficult laryngoscopic view in neurosurgical patients

PGIMER1 个研究点 分布在 1 个国家目标入组 562 人开始时间: 2022年11月29日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
PGIMER
入组人数
562
试验地点
1
主要终点
To demonstrate that thyromental height has a sensitivity and specificity of more than 75% in predicting a difficult laryngoscopes view.

研究概览

简要总结

The hypothesis is that Thyromental height will have a higher sensitivity in predicting a difficult laryngoscopic view than routinely performed airway assessment parameters such as Modified Mallampati Test and Thyromental Distance.

The primary objective will be to arrive at a sensitivity/specificity of more than 75% of thyromental height in predicting a difficult laryngoscopic view.

The secondary objectives would be 1)to arrive at a cut off value for thyromental height to predict difficult laryngoscopic view, 2)PPV,NPV and accuracy of thyromental height and 3)To compare Thyromental height with Modified Mallampati test and thyromental distance.

The study will target to recruit 562 patients undergoing neurosurgical procedures. Due to the limited time frame however at least 250 patients will be recruited. The thyromental height will be measured along with other airway parameters during the Pre anaesthesia evaluation and will be done within 12 hours of surgery. The intubation will be carried out an experienced anaesthesiologist of at least 3 years experience and the Cormack Lehane grading will be recorded.

A difficult laryngoscopic view will be defined as a grade of 3 or 4.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Neurosurgical patients undergoing surgery for glioma, aneurysm,c spine, traumatic brain injury, vp shunt, cerebellar lesions, brainstem lesions under general anaesthesia.

排除标准

  • Cervical spine abnormalities, pregnancy, facio maxillary deformity, BMI >30, neuromuscular disorders.

结局指标

主要结局

To demonstrate that thyromental height has a sensitivity and specificity of more than 75% in predicting a difficult laryngoscopes view.

时间窗: Within 24 hours of surgery and Cormack Lehane grading upon intubation.

次要结局

  • To calculate a cut off value for thyromental height.(To calculate the positive predictive value, negative predictive value and accuracy of thyromental height in predicting a difficult laryngoscopes view.)

研究者

发起方
PGIMER
申办方类型
Research institution

研究点 (1)

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