A Cross sectional Observational Study to Evaluate Predictive Value of Modified Mallampati Test Alone & in Conjunction with Voice Analysis for Difficult Laryngoscopy During General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To evaluate the predictive potential of modified Mallampati test alone and in conjunction with voice parameters for difficult laryngoscopy
研究概览
简要总结
Airway risk assessment is an essential part of the preoperative anaesthetic protocol. Numerous investigations have been conducted in an effort to predict the occurrence of difficult airway through physical examination & modified Mallampati test is the most popular one. But Research has shown that it only had moderate ability to predict difficult airway.
Voice signal is a more recent novel and comprehensive indicator that can reflect both anatomical structure and function of the airway. So, voice analysis may offer a way to predict difficulty in airway manipulation.
This study aimed to determine whether acoustic features are valuable as method to predict difficult laryngoscopy (DL) when it is used alone and in conjunction with modified Mallampati test in patients scheduled to undergo elective surgery under general anaesthesia.
This study will include 250 adult patients who will be undergoing elective surgery under general anaesthesia with tracheal intubation. Preoperatively, clinical airway evaluation will be performed and modified Mallampati grading will be done.The Class I &II is associated with easy laryngoscopy & Class III or IV is usually associated with difficult laryngoscopy.
Five phonemes considered as the vowels a, e, i, o,u will be recorded and their first four formants (describe as f1, f2, f3, f4 ) will be analysed. Laryngoscopy will be done after induction of anaesthesia & adequate muscle relaxation. Difficult Laryngoscopy will be called when the anaesthetist, using direct laryngoscopy, classified the patient as 3 or 4 in accordance with the Cormack and Lehane classification system.
It is expected that voice parameters in conjunction with modified Mallampati test will have higher predictive value to predict difficult laryngoscopy & intubation than modified mallampati test alone during general anaesthesia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients planned for elective Surgery under General Anaesthesia with tracheal intubation 2.Patients with ASA Grade I and II.
排除标准
- •1.Patients with ASA Grade III and IV 2.Patient with a previous history of speech disorders,larengeal & vocal cord diseases, cleft palate, craniofacial syndromes, craniofacial trauma, previous oral and maxillofacial surgery, 3.Patient with hearing or perception abnormalities, mental or central nervous system diseases, 4.Pregnancy 5.Patients refusing consent 6.Patient admitted for emergency surgery.
- •7.History of difficult laryngoscopy in past 8.Patients participated in other relevant clinical investigation in the past 3 months.
结局指标
主要结局
To evaluate the predictive potential of modified Mallampati test alone and in conjunction with voice parameters for difficult laryngoscopy
时间窗: During pre anaesthetic check up((baseline) and laryngoscopy before intubation(4wks)
次要结局
- 1.To determine correlation of different voice parameters to difficult laryngoscopy(2.To determine predictive value of modified Mallampati test for difficult laryngoscopy)
研究者
Dr Debraj Roy
KPC Medical College and Hospital