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CTRI Number  CTRI/2025/03/083729 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparing Stop Bang And Other Tests in Predicting Difficult Airway 
Scientific Title of Study   Stop Bang Questionnaire is a Better Predictor for Determining Difficult Airway When Compared to Other Bedside Predictors - 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  Jayadurga D 
Designation  Post graduate MSc Anaesthesia Technology 
Affiliation  SRM medical college and hospital SRM Nagar Potheri 
Address  Room no 22 Department of Anaesthesiology SRM Medical College And Hospital Chennai TAMILNADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  8778556831  
Fax    
Email  jayanivi1902@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr KARTHIK K 
Designation  Professor 
Affiliation  SRM medical college and hospital SRM Nagar Potheri 
Address  Room no 22 Department of Anaesthesiology SRM Medical College And Hospital Chennai TAMILNADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884360796  
Fax    
Email  karthikk2@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr KARTHIK K 
Designation  Professor 
Affiliation  SRM medical college and hospital SRM Nagar Potheri 
Address  Room no 22 Department of Anaesthesiology SRM Medical College And Hospital Chennai TAMILNADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884360796  
Fax    
Email  karthikk2@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital & Research Centre SRM Nagar potheri kancheepuram,Tamilnadu-603203,India. 
 
Primary Sponsor  
Name  SRM Medical College and Hospital  
Address  SRM Medical College and Hospital SRM Nagar Potheri 603203 
Type of Sponsor  Private 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 k karthik  SRM Medical College Hospital & Research Centre  Room no 22,2nd floor Pre Operative Assessment and Operation Theatre Complex Department of Anaesthesiology
Kancheepuram
TAMIL NADU 		 9367720331

jayanivi1902@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital & Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient Age between 18 to 60 yrs
ASA I II and III Patients
Patient scheduled for an Elective surgery under General Anaesthesia 
 
ExclusionCriteria 
Details  Patient above 60 yrs of Age
ASA IV Patients
Unconscious Unoriented and Uncooperative Patients
Obstetric Patients
Patient Refusal 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the use of STOP-BANG Questionnaire in predicting the Difficult Airway  Assessed Preoperatively and During Intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To Correlate the Questionnaire and Difficult Airway Tests  Preoperative Assessment and During Airway Management 
 
Target Sample Size   Total Sample Size="197"
Sample Size from India="197" 
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)   01/05/2025 
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   INTRODUCTION 
         Airway Evaluation is one of the most important aspects of Preoperative Patient Assessment. Airway management is a key feature in the safety and quality of Anaesthesia. Difficult Airway management remains the most common cause of Anaesthesia related morbidity and mortality. Several factors can predict the incidence of Difficult airway, Obstructive Sleep Apnoea Syndrome being one such factor. There are several screening tools for OSAS. STOP BANG Questionnaire is an established tool for Obstructive Sleep Apnea Syndrome Screening. Depending on the score, the STOP BANG questionnaire has aided anesthesia providers in making appropriate alterations in intraoperative care plans to avoid difficult airway. This study aimed to estimate the accuracy of commonly used airway examination tests and correlate them with the questionnaire for assessing difficult airway.
METHODOLOGY
        This study will be conducted on patients scheduled for elective surgery requiring General Anesthesia with Endotracheal intubation.  In The Pre Operative Evaluation Patients will be instructed to sit straight and Age, Gender, Body Mass Index, Blood pressure, Neck Circumference, Interincisor Gap, Sternomental and Thyromental Distance, Head and Neck movement, Buck Teeth, Upper lip Bite test, and Mallampati Grades will be recorded. In addition, all patients will be asked to answer the STOP BANG Questionnaire. A score of greater than or equal to five on the STOP BANG Questionnaire predicts severe OSAS. The Frequency of Difficult Airway will be higher in the patients with a score of eleven to fourteen in other Bedside predictor tests. On the Day of surgery, each patient will be taken to the operating room and Laryngoscopy and Intubation will be performed in a standard Sniffing position. Upon induction of General anesthesia, the degree of difficulty encountered during Mask ventilation and Intubation will be documented. In classical Laryngoscopy, the glottic view is evaluated using the Cormack and Lehane grading system. Difficult Intubation will be more frequent in patients with a score of greater than six.
EXPECTED OUTCOME
         The study is expected to show that the STOP BANG Questionnaire is a better predictor of difficult airway compared to other bedside tests. It may demonstrate higher specificity, sensitivity, and predictive accuracy, particularly in patients with Obstructive Sleep Apnea. The findings could lead to improved airway assessment protocols and better preparedness for difficult airway management.
         
         
 
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