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CTRI Number  CTRI/2025/02/080463 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Airway using Ultrasound and Clinical airway tests 
Scientific Title of Study   Comparative Assessment of Airway using Ultrasound and Conventional method : A Prospective Observational Study in 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 Indu Verma 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Hospitals 
Address  Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Indu Verma 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Hospitals 
Address  Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rupanchakravarthy S 
Designation  Junior Resident 
Affiliation  SAWAI MANSINGH MEDICAL COLLEGE 
Address  Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9597099455  
Fax    
Email  rupandgl4@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, SMS Medical College and Hospitals, JLN Marg, Jaipur, Rajasthan 302002  
 
Primary Sponsor  
Name  SMS Medical College and Hospitals 
Address  Department of Anaesthesia, SMS Medical College and Hospital, JLN Marg, Jaipur, Rajasthan-302002  
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 Indu Verma  Cardiac OT, SMS Medical College and Hospitals  Department of Anaesthesia,2nd floor, Dhanvantri Complex, SMS Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN 
9413622967

dr.induverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional methods and Ultrasonography measurements.  comparing Conventional methods like Mallampatti score, thyromental distance with ultrasonography measurement of skin to epiglottis distance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists (ASA) physical status classification score of I - III
2. Patient’s body mass index less than 40kg/m2
3. Patients undergoing elective surgical procedure requiring endotracheal intubation
 
 
ExclusionCriteria 
Details 
1. Patient not willing to give consent
2. Pre-existing airway malformations
3. Pathologies like facial or cervical fractures, maxilla facial abnormalities, cervical tumors and goiter
4. History of difficult intubation
5. Patients with tracheostomy tubes
6. Pregnant patients
7. Patients with body mass index more than 40kg/m2
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To Find the Effectiveness of Sonographic Measurement of the Distance from the Skin to the Epiglottis in Predicting Difficult Laryngoscopy.  To Find the Effectiveness of Sonographic Measurement of the Distance from the Skin to the Epiglottis in Predicting Difficult Laryngoscopy. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To clinically assess the thyromental distance & Mallampati score for predicting difficult intubation.
2.To assess the Cormack-Lehane score for predicting difficult intubation during laryngoscopy. 
1.To clinically assess the thyromental distance & Mallampati score for predicting difficult intubation.
2.To assess the Cormack-Lehane score for predicting difficult intubation during laryngoscopy. 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  

Patient arrival in pre anesthetic room, identification of patient and demographic details obtained

The following preanesthetic evaluations are done,

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

        2. General physical examination

        3. Clinical tests in airway examination

        4. Ultrasonography measurement of skin to epiglottis distance

        Vital parameters like B.P., Pulse, SpO2, Temperature, Respiratory rate

 Routine investigations: Hb, TLC, DLC, Bleeding Time, Clotting Time, PT-INR, Fasting blood sugar, Serum urea, Serum creatinine, SGOT, SGPT, Serum Electrolytes, Chest X-Ray, ECG, 2D-ECHO, coronary artery angiography (if required)

Patient received in OT identified, consent, NBM checked, monitored with ECG, NABP, pulse oximetry and capnography

 Preoxygenation will be done with 100% oxygen for 3-5 minutes.

 Anesthesia will be induced with Injection Propofol 2mg /kg and Injection Rocuronium Bromide 0.8 mg/kg IV, ventilated with oxygen and isoflurane 1.5% for 3min.

 Direct laryngoscopy is done with appropriate Macintosh blade by an anesthesiologist with more than 2 years of experience (post qualification) Cormack Lehane (CL) laryngoscopic grade was noted, Position of tube will be checked by 5-point auscultation method & capnography.

Intubating anesthesiologist was not involved in preoperative airway evaluation (clinical tests and sonographic airway assessment

Anesthesia maintained with isoflurane, booster doses of rocuronium and fentanyl as needed.

Based on the preoperative airway findings, intubation is categorized as either easy or difficult, with the aim of determining which factor is the better predictor of airway difficulty.

 
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