Airway Ultrasound for Prediction of difficult laryngoscopy using tongue thickness skin to epiglottis distance and hyomental distance a prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Correlation of three ultrasound-based predictor tongue thickness skin-to-epiglottis distance and hyomental distance together with difficult airway
研究概览
简要总结
Title Airway Ultrasound for Prediction of Difficult Laryngoscopy Using Tongue Thickness Skin to Epiglottis Distance and Hyomental Distance A Prospective Observational Study
Background and Need for Study
Difficult airway during anesthesia increases the risk of complications.
Traditional assessment methods like Mallampati score and thyromental distance are not very accurate.
Ultrasound provides a safe and real-time method to examine the airway.
There is a need to validate ultrasound-based measurements for predicting difficult laryngoscopy
Objectives
Primary Objective
To assess the relationship between ultrasound measurements and difficult laryngoscopy based on Cormack Lehane grading
Secondary Objectives
To compare each ultrasound parameter individually and in combination
To find the best cut off values for prediction
To compare ultrasound results with traditional clinical airway tests
Methodology
Study Type Prospective observational clinical study
Duration One year and six months from May 2025 to November 2026
Sample Size 526 adult patients aged 18 to 65 undergoing elective surgery under general anesthesia
Inclusion ASA Class I to III, normal mouth opening and neck mobility
Exclusion Facial deformity, neck pathology, morbid obesity, pregnancy, previous airway surgery
Preoperative ultrasound measurements include
Tongue thickness
Skin to epiglottis distance
Hyomental distance in neutral and extended positions
Laryngoscopy performed by a separate anesthesiologist who is unaware of the ultrasound findings
Analysis
Statistical tools include regression analysis and ROC curve
Main outcome is correlation of ultrasound findings with difficulty in laryngoscopy
Additional outcomes include accuracy of each parameter and comparison with clinical scores
Importance
If successful this method can help in better preparation for airway management and improve patient safety before anesthesia
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
- •Adult patients aged 18 to 65 years ASA Physical Status I to III Scheduled for surgeries under general anesthesia requiring orotracheal intubation Normal mouth opening and neck mobility.
排除标准
- •Facial deformity Tumors Prior airway surgery Morbid obesity BMI more than 40 kg m² Pregnant women Neck pathology swelling masses cervical spine deformity Cervical spine instability Refusal to participate in the study.
结局指标
主要结局
Correlation of three ultrasound-based predictor tongue thickness skin-to-epiglottis distance and hyomental distance together with difficult airway
时间窗: Preoperative 30 minutes before induction | Intraoperative 2 mins after induction
次要结局
- Optimal cut-off values for each ultrasound parameter associated with difficult laryngoscopy.
- Correlation of each of the individual ultrasound parameters or combination of two parameters with difficult laryngoscopy(Preoperative 30 mins before induction of patient)
- Comparison with standard clinical predictors Mallampati classification thyromental distance in terms of predictive performance(Preoperative before day of surgery)
- Incidence of difficult laryngoscopy defined by Cormack Lehane grades during direct laryngoscopy in correlation with preoperative ultrasound measurements of tongue thickness skin to epiglottis distance & hyomental distance(Preoperative 30 mins before induction of patient)
研究者
V Veer partha sarathi
Ballari medical College and research centre