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临床试验/CTRI/2025/07/090562
CTRI/2025/07/090562尚未招募不适用

Evaluation of predictive ability of sonography based airway assessment parameters and clinical parameters as predictors of difficult laryngoscopy and intubation: An Observational Clinical Study

Sir Sayaji Rao Gaekward Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年7月20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
54
试验地点
1
主要终点
The primary outcome of this study is to determine the predictive ability of sonography-based airway assessment parameters as predictors of difficult laryngoscopy and intubation using POGO score (percentage of glottic opening) and intubation difficulty scale (IDS)

研究概览

简要总结

Routine preoperative airway assessment aids in the proper management of difficult airway conditions. Clinical screening tests used routinely in airway assessment lack adequate sensitivity and specificity for detecting difficult laryngoscopy. Ultrasound is a non-invasive procedure and allows real-time visualization of anatomical structures, aiding in rapid assessment. It helps gauge parameters like airway patency, identify potential obstructions, and assess the position of vocal cords. This dynamic imaging enhances decision-making during interventions such as intubation through optimal preparation involving appropriate choice of equipment before managing airway.

In this study we aim for comprehensive use of ultrasound airway parameters along with clinical airway parameters in airway management through Clinical parameters:

1.MO - Mouth opening

2.MMG - Modified Mallampati grade

3.ULBT - upper lip bite test

4.TMD - thyromental distance

5.MHD - myohyoid distance

6.NC - neck circumference,

and sonography based parameters:

1.HMDN - hyomental distance neutral neck

2.HMDE - hyomental distance extended neck

3.TW - tongue width

4.TT - tongue thickness

5.SED - skin to epiglottis distance

6.SVC - skin to vocal cords distance

7.ANS TM - anterior neck soft tissue distance at level of thyrohyoid membrane

8.ANS Hyoid bone - anterior neck soft tissue distance at level of hyoid bone

and POGO score (Percentage of glottic opening) on direct laryngoscopy and IDS (Intubation Difficulty Scale) as key metrics.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing and giving consent for the procedure.
  • 2.Patients posted for Elective Surgeries under Department of General Surgery SSG Hospital requiring Endotracheal Tube pacement.
  • 3.Patients conformed to American Society of Anaesthesiologist (ASA) physical status Grade I, II, III in preoperative assessment.

排除标准

  • 1.Patients with past history of difficult laryngoscopy or difficult intubation.
  • 2.Pregnant women.
  • 3.Obese patients with Basal Metabolic Index of 40 or higher.
  • 4.Patients with noticeable swelling in the neck region.
  • 5.Patients with maxillofacial anomalies.
  • 6.Patients with history of burns and neck skin contracture.

结局指标

主要结局

The primary outcome of this study is to determine the predictive ability of sonography-based airway assessment parameters as predictors of difficult laryngoscopy and intubation using POGO score (percentage of glottic opening) and intubation difficulty scale (IDS)

时间窗: Till 4 weeks

次要结局

  • The secondary outcome is to determine the predictive ability of clinical airway predictors & to evaluate the efficacy in terms of specificity & sensitivity of clinical & sonographic airway parameters for predicting difficult laryngoscopy & difficult intubation.(Till 4 weeks)

研究者

发起方
Sir Sayaji Rao Gaekward Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vishakha Sinsinwal

Sir Sayaji Rao Gaekward Hospital

研究点 (1)

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