跳至主要内容
临床试验/CTRI/2025/09/093980
CTRI/2025/09/093980尚未招募不适用

A Prospective study to predict difficult airway in adult patients by using preoperative ultrasound based measurements of airway parameters at sms medical college jaipur

Sawai Man Singh Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年11月1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
136
试验地点
1
主要终点
1.To evaluate the accuracy of ultrasonographic measurements of Distance from hyoid bone to skin and distance from the skin to epiglottis midway between the hyoid bone and thyroid cartilage, and the occurenceof difficult laryngoscopies in adult patients undergoing intubation.

研究概览

简要总结

All patients will be visited on the day prior to surgery and explained about the anaesthetic technique and perioperative course. Each patient will have a pre anaesthetic checkup that includes:

1.Any significant present/past medical or surgical history, any drug allergy history will  be noted.

2.General physical examination will be done.

3.Airway examination include Mallampati scores (MMP) , inter incisor distances and will be measured. Mallampati grading 1and 2 and inter incisor gap more than 3 fingers will be taken for study.

4.Vital parameters like Blood pressure, Pulse, SpO2, Temperature, Respiratory rate will be measured.

5.Routine investigations like Hb, TLC, DLC, Bleeding Time, Clotting Time, PT-INR, Fasting blood sugar, Serum urea, Serum creatinine, SGOT, SGPT, Serum Electrolytes, Chest X-Ray, ECG to be done.

6.Written and informed consent will be obtained for general anaesthesia after complete explanation about the study protocol.

7.The antihypertensive medications used by the patients will be recorded.

8.An assessment of the airway using ultrasonography (USG) will be performed preoperatively. Patients will be positioned supine with their heads in a neutral position without any support, chin lifted, mouth closed, and tongue touching the floor of the mouth. They will be instructed to look straight ahead and refrain from making any movements. A linear high-frequency probe will be placed in the submandibular area in the midline to obtain measurements of the thickness of the anterior soft tissue in the transverse view at two levels which are the level of the hyoid bone (Distance from Hyoid Bone to Skin (DSHB)) and the level of the thyrohyoid membrane (distance from the skin to the epiglottis midway between the hyoid bone and the thyroid cartilage (DSEM)).

9.Parameters to be observed will include the thickness of the anterior neck soft tissue in the transverse view at the level of the hyoid bone (Distance from Hyoid Bone to Skin (DSHB)) and the thickness of the anterior neck soft tissue in the transverse view at the level of the thyrohyoid membrane (distance from the skin to the epiglottis midway between the hyoid bone and the thyroid cartilage (DSEM)).

10.Following clinical and USG airway assessment, patients will be classified as having a difficult or easy laryngoscopy based on predetermined criteria for the USG parameters. A distance from the skin to the epiglottis midway between the hyoid bone and the thyroid cartilage (DSEM) value greater than 2.03 cm will be classified as a difficult airway, while a value less than 2.03 cm will be classified as an easy airway. A Distance from Hyoid Bone to Skin (DSHB) value greater than 0.66 cm will be categorized as a difficult airway, while a value less than 0.66 cm will be categorised as an easy airway.

11.Upon arrival in the operating room, an intravenous (IV) line will be secured, and patients will be pre-medicated with injections of glycopyrrolate 0.005 mg per kg and fentanyl 2 mcg per kg, followed by preoxygenation with 100 percent oxygen for three minutes. Induction will be performed using Injection propofol 2 mg per kg, and neuromuscular blockade will be achieved with Injection succinyl choline 2 mg per kg IV. Direct laryngoscopy will be conducted by an anaesthesiologist using an appropriately sized curved Macintosh blade, and the Cormack Lehane (CL) grade will be recorded. Cormack Lehane grades I and II will be considered as easy laryngoscopies. Following laryngoscopy, patients will be intubated with an appropriately sized endotracheal tube laryngoscopy, patients will be intubated with an appropriately sized endotracheal tube and prepared for surgery to commence.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 undergoing surgery under general anaesthesia requiring endotracheal intubation.
  • 2.Patients giving informed written consent.
  • 3.Patients aged between 18 to 60 years.
  • 4.BMI less than 25kg per metre square.
  • 5.Patients with an American Society of Anaesthesiologists(ASA) physical status of 1 and 2.

排除标准

  • 1.Patients should not be part of any other study.
  • 2.Patients with a history of difficult intubation.
  • 3.Patients with head and neck anatomical pathologies.
  • 4.Patients with restricted neck movements.
  • 5.Pregnant patients.
  • 6.Patients with maxillofacial anomalies.
  • 7.Patients who are edentulous.

结局指标

主要结局

1.To evaluate the accuracy of ultrasonographic measurements of Distance from hyoid bone to skin and distance from the skin to epiglottis midway between the hyoid bone and thyroid cartilage, and the occurenceof difficult laryngoscopies in adult patients undergoing intubation.

时间窗: Baseline parameters will be taken preoperatively.

2.To compare the accuracy of ultrasonographic parameters with Cormack-Lehane grading system,in identifying difficult laryngoscopies.

时间窗: Baseline parameters will be taken preoperatively.

次要结局

未报告次要终点

研究者

发起方
Sawai Man Singh Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mamta Khandelwal

Sawai Man Singh Medical College, Jaipur

研究点 (1)

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