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CTRI Number  CTRI/2025/10/095831 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational study 
Study Design  Other 
Public Title of Study   Comparison of Ultrasound parameters versus Clinical scores in prediction of difficult airway in obese patients 
Scientific Title of Study   Comparison of Ultrasound guided airway parameters versus Simplified airway risk index score for prediction of difficult airway in obese patients A Prospective Observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saipriya 
Designation  Junior Resident 
Affiliation  All India Institute Of Medical Sciences , Bhopal 
Address  Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  9841604196  
Fax    
Email  saipriya4196@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences , Bhopal 
Address  Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  9340969292  
Fax    
Email  pooja.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Pooja Singh 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences , Bhopal 
Address  Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal

Bhopal
MADHYA PRADESH
462020
India 
Phone  9340969292  
Fax    
Email  pooja.anesth@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences,Saket Nagar,MadhyaPradesh, Bhopal-462020 
 
Primary Sponsor  
Name  Dr Pooja Singh 
Address  Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal, Madhya Pradesh,India,462020 
Type of Sponsor  Research institution and hospital 
 
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 
Saipriya  AIIMS BHOPAL  Modular Operation Theatre, Department of Anaesthesiology, AIIMS Bhopal
Bhopal
MADHYA PRADESH 
9841604196

saipriya4196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee-Student Research (IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18-75 years
Either sex
Patients having body mass index more than 30
Patients undergoing surgery under general
anaesthesia 
 
ExclusionCriteria 
Details  Emergency surgery
Distorted airway anatomy

Blunt or penetrating Maxillofacial
trauma
Supraglottic and glottic lesions
Grade II and III trismus
Infection, burns and anaphylaxis
leading to severe oedema and
swelling of the airway
Micrognathia
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
. To compare the accuracy of ultrasound-guided airway parameters versus simplified
airway risk index in predicting difficult laryngoscopy and intubation in obese patients
using percentage error, positive and negative predictive value 
24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the sensitivity, specificity & threshold cut-off for ultrasound-guided airway
parameters using the ROC-AUC curve.
2. To assess the sensitivity, specificity & threshold cut-off for Simplified airway risk
index parameters using ROC-AUC curve. 
48 weeks 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   24/10/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

On the day of surgery, all patients will receive an injection pantoprazole 40 mg and injection ondansetron 4 mg for aspiration prophylaxis in the preoperative room. After ensuring routine fasting ,all patients were monitored using electrocardiography, non-invasive blood pressure, pulse oximetry, and temperature monitoring on the day of the operation. Preoxygenation will be performed for 3 min while the patient will be kept in the ramp position. Standard anesthesia induction (propofol 2 mg.kg-1, fentanyl 2 mcg.kg-1, rocuronium bromide 0.6 mg.kg-1 intravenously) will be done. After 3 minutes of bag and mask ventilation (with or without adjunct such as oral or nasal airway), direct laryngoscopy and intubation will be performed using an appropriate size video laryngoscope. An Anesthesiologist with at least 3 years of experience will perform laryngoscopy and intubation.

Laryngoscopy and intubation difficulty level for both clinical assessment using (SARI) score and ultrasound assessment of airway will be validated against Intubation Difficulty Scale. The IDS score is the sum of these seven parameters viz: (1) Number of attempts, (2) Number of additional operators, (3) Alternative techniques, (4) Cormack-Lehane grade, (5) Lifting force, (6) External laryngeal pressure, (7)vocal cord mobility. The score interpretation 0: Easy intubation, 1-5: slightly difficult intubation,>5:moderate to major difficulty.

 
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