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临床试验/CTRI/2025/09/094791
CTRI/2025/09/094791招募中不适用

Role of ultrasonographic parameters in DARES criteria for improving the quality, safety and efficacy of airway management: A prospective study.

Government medical college, kottayam1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
The primary outcome will be

研究概览

简要总结

Airway management involves preoperative evaluation. Ultrasonography is a very good method by predicting Cormack  lehane score and correlating with difficult laryngoscopy. Dares criteria involves Distance from skin to epiglottis, hyo mental distance, hyo mental distance ratio 1 , (ratio of hyo mental distance in ramped position to head in neutral position0. and hyo mental distance ratio 2 ( Hyo mental distance in hyperextended position to  neutral position)and  Tongue thickness . Cormack lehane score on direct laryngoscopy grade 3 and 4 is difficult laryngoscopy.HMDR1 less than 1.12 and HMDR2 less than 1.08, Tongue thickness more than 6cm and Distance from skin to epiglottis more than 2.5cm is the cutoff for difficult laryngoscopy. Area under the curve , sensitivity and specificity of the predictive model can be used for predicting difficult laryngoscopy

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex, ASA I or II, scheduled for surgical procedures under general anesthesia requiring intubation at Government Medical College, Kottayam during 2025-2026.

排除标准

  • The exclusion criteria for ultrasonographic study will be limited neck mobility secondary to cervical spine fractures or tumours, limited neck extension including arthritis, documented history of difficult intubation, pregnant women, post burns contracture of neck or perioral region.

结局指标

主要结局

The primary outcome will be

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

1.Indication of surgery

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

2.Predictors (clinical and ultrasonographic) of difficult face mask ventilation or intubation

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

3.To determine the Total intubation time (in seconds)

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

4.To compare the visualization of airway using Modified Cormack-Lehane grading.

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

5.To assess the ease of intubation (score)

时间窗: Date of first enrolment : 01- 10- 2025. | Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024

次要结局

  • 1.Number of intubation attempts required(2.Any rescue devices used.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sheeba franklin

Government Medical College Kottayam

研究点 (1)

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