FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/093980 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   A study to predict difficult airway in adult patients by using preoperative ultrasound based measurement of airway parameters 
Scientific Title of Study   A Prospective study to predict difficult airway in adult patients by using preoperative ultrasound based measurements of airway parameters at sms medical college jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur,302001,Rajasthan,India

Jaipur
RAJASTHAN
302001
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Khandelwal 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur,302001,Rajasthan,India

Jaipur
RAJASTHAN
302001
India 
Phone  9929338174  
Fax    
Email  drmamtakhandelwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arnav Chawla 
Designation  PG Student 
Affiliation  Sawai Man Singh Medical College, Jaipur 
Address  Department of Anesthesiology, Second floor, Dhanwantri Building, JLN Marg, Jaipur, 302001,Rajasthan,India

Jaipur
RAJASTHAN
302001
India 
Phone  8607545500  
Fax    
Email  arnavchawla1@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, SMS Medical College,Jaipur 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College and Hospital 
Address  Department of Anaesthesiology, Second Floor, Dhanvantri OPD Block, SMS Hospital, Jaipur,Rajasthan,302004,India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mamta Khandelwal  SMS Medical College and Hospital  Department of Anesthesiology,Second Floor, Dhanwantri Building, SMS Hospital,JLN Marg, Jaipur, Rajasthan,302004,India
Jaipur
RAJASTHAN 		 9929338174

drmamtakhandelwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Comitte, SMS Medical College and Attached Hospitals, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional methods and Ultrasonography Measurements  Comparing conventional methods like Mallampatti score and cormack lehane grading with ultrasonography measurements of hyoid bone to skin and distance from skin to epiglottis midway between the hyoid and the thyroid cartilage in identifying difficult laryngocopies in adult patients. 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.
2.To compare the accuracy of ultrasonographic parameters with Cormack-Lehane grading system,in identifying difficult laryngoscopies. 		 Baseline parameters will be taken preoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
Close