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临床试验/CTRI/2025/10/095831
CTRI/2025/10/095831尚未招募不适用

Comparison of Ultrasound guided airway parameters versus Simplified airway risk index score for prediction of difficult airway in obese patients A Prospective Observational study

Dr Pooja Singh1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年10月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
. To compare the accuracy of ultrasound-guided airway parameters versus simplified

研究概览

简要总结

On the day of surgery, all patients will receive an injection pantoprazole 40 mg and injection ondansetron 4 mg for aspiration prophylaxis in the preoperative room. After ensuring routine fasting ,all patients were monitored using electrocardiography, non-invasive blood pressure, pulse oximetry, and temperature monitoring on the day of the operation. Preoxygenation will be performed for 3 min while the patient will be kept in the ramp position. Standard anesthesia induction (propofol 2 mg.kg-1, fentanyl 2 mcg.kg-1, rocuronium bromide 0.6 mg.kg-1 intravenously) will be done. After 3 minutes of bag and mask ventilation (with or without adjunct such as oral or nasal airway), direct laryngoscopy and intubation will be performed using an appropriate size video laryngoscope. An Anesthesiologist with at least 3 years of experience will perform laryngoscopy and intubation.

Laryngoscopy and intubation difficulty level for both clinical assessment using (SARI) score and ultrasound assessment of airway will be validated against Intubation Difficulty Scale. The IDS score is the sum of these seven parameters viz: (1) Number of attempts, (2) Number of additional operators, (3) Alternative techniques, (4) Cormack-Lehane grade, (5) Lifting force, (6) External laryngeal pressure, (7)vocal cord mobility. The score interpretation 0: Easy intubation, 1-5: slightly difficult intubation,>5:moderate to major difficulty.

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

  • Age 18-75 years Either sex Patients having body mass index more than 30 Patients undergoing surgery under general anaesthesia.

排除标准

  • Emergency surgery Distorted airway anatomy Blunt or penetrating Maxillofacial trauma Supraglottic and glottic lesions Grade II and III trismus Infection, burns and anaphylaxis leading to severe oedema and swelling of the airway Micrognathia Pregnancy.

结局指标

主要结局

. To compare the accuracy of ultrasound-guided airway parameters versus simplified

时间窗: 24 weeks

airway risk index in predicting difficult laryngoscopy and intubation in obese patients

时间窗: 24 weeks

using percentage error, positive and negative predictive value

时间窗: 24 weeks

次要结局

  • 1. To assess the sensitivity, specificity & threshold cut-off for ultrasound-guided airway(parameters using the ROC-AUC curve.)

研究者

发起方
Dr Pooja Singh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Saipriya

All India Institute Of Medical Sciences , Bhopal

研究点 (1)

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