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CTRI Number  CTRI/2025/08/093429 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To assess the relationship between the shape of structure protecting voice box and the challenge of inserting a tube into the airway after anaesthesia during surgery  
Scientific Title of Study
Modification(s)  
To determine the relationship between shapes of epiglottis and the incidence of difficult endotracheal intubation - A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinobharathi E 
Designation  Postgraduate registtrar 
Affiliation  Christian medical College  
Address  Christian medical College Department of anesthesia Vellore Taminadu

Vellore
TAMIL NADU
632004
India 
Phone  9003850842  
Fax    
Email  vinosri.bharathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Balaji R 
Designation  Professor  
Affiliation  Christian medical college 
Address  Christian medical College Department of anaesthesia Vellore Tamilnadu

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinobharathi E 
Designation  Postgraduate registrar 
Affiliation  Christian medical college 
Address  Christian medical College Department of anaesthesia Vellore Tamilnadu

Vellore
TAMIL NADU
632004
India 
Phone  9003850842  
Fax    
Email  vinosri.bharathi@gmail.com  
 
Source of Monetary or Material Support  
Institutional fluid grant Christian medical College Vellore 632004 Tamilnadu 
 
Primary Sponsor  
Name  Institutional fluid grant Christian medical college  
Address  Christian medical College Vellore 632004 Tamilnadu  
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 Vinobharathi E  Christian medical college Vellore  Department of Anaesthesia Christian Medical College Vellore Vellore Tamilnadu
Vellore
TAMIL NADU 
09003850842

vinosri.bharathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Review board,Christian medical college  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Elective surgery
All asa 1,2,3
Normal anatomical airway 
 
ExclusionCriteria 
Details  Asa 4 and 5
Age more than 60 and less than 20years
Emergency surgery
Syndromic facies
Anticipated difficult airway
Facial deformity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the relationship of epiglottis shape and the difficult intubation
 
After preop consent patient undergoing Surgery with general anaesthesia the intubation will be done with usual mac 3 blade without stylet during laryngoscopy the epiglottis is assessed and if unanticipated difficulty arises any change in the intubation techniques like usage of stylet external maneuver blade change usage of bougie cmac the intubation difficulty is then compared with Cormack lehange scopy grading and difficulty is categorised  
 
Secondary Outcome  
Outcome  TimePoints 
To provide recommendation for airway management based on epiglottis shape  During laryngoscopy once the epiglottis shape is identified & the shape coming under difficulty shape type then the intubation techniques will be modified immediately without any delay  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/09/2025 
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 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   As an anesthesiologist airway management is our biggest concern in unanticipated situations with difficult airways. Even though patients are assessed in the pre anesthetic clinic with clinical airway assessments and general physical examinations prior to the procedure, unanticipated difficult airways can occur on the table.
It is known that the Cormack and Lehane grading system is used to predict intubation difficulty. However the shape of the epiglottis affects the visible range of the vocal cords. Research has shown that the shape of the epiglottis can have a significant impact on airway difficulty during intubation. A normally shaped epiglottis is associated with easier intubation, while abnormally shaped epiglottis, like omega shaped or floppy, have an increased risk of difficult intubation.
Anesthesiologists should assess the shape of the epiglottis during laryngoscopy and consider alternative intubation techniques or assistive devices, such as bougies, video laryngoscopes, fiberoptic scopes, or calling upon expert senior personnel for difficult intubation. By understanding the relationship between the shape of the epiglottis and intubation difficulty, anesthesiologists can improve airway management in difficult situations and improve patient outcomes. By recognizing the problems associated with the shapes of the epiglottis, physicians can devise better airway management strategies to overcome difficulties and ensure patient safety through successful airway securement.
 We have planned to conduct this study in operating rooms of our instituition going on all patients undergoing elective surgery and intubation with endotracheal tube on under general anaesthesia with endotracheal intubation
           This prospective observational study aims to estimate the relationship between the shape of the epiglottis and the ease of endotracheal intubation, and to identify the implications of epiglottis shape on airway management. Patients will be recruited on the basis of inclusion and exclusion criteria, and informed consent will be obtained by the primary investigator.
                   With adequate fasting the patient will receive general anaesthesia using standard induction agents chosen by the anaesthesiologist in the operating room. The senior anaesthesiologist will perform the laryngoscopy with adequate relaxation and depth of anaesthesia using a standard mac 3 blade and an endotracheal tube without a stylet, and assess the shape of the epiglottis at laryngeal expansion. If unanticipated difficulty is encountered, any modification in the intubation techniques, such as the usage of a stylet, bougie, change of blade, or videolaryngoscopy, will be noted. The difficulty of intubation will be graded with Cormack Lehane laryngoscopy grading and the data will analysed

 
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