| 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
|
|
|
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
|
|
|
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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