| CTRI Number |
CTRI/2026/01/100078 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking the airway and spotting the difficulties in securing the airway in two different group of people
|
|
Scientific Title of Study
|
Evaluation of airway and predicting difficult endotracheal intubation in diabetic patients a comparison with non diabetic patients |
| 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 M SENTHIL |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room no 15,Department of Anesthesiology, VMKVMCH,SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M SENTHIL |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room no 15,Department of Anesthesiology, VMKVMCH,SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M SENTHIL |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room no 15,Department of Anesthesiology, VMKVMCH,SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions Kirupananda Variyar Medical College and Hospitals,SALEM-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Chinnaseragapadi,SALEM,636308 |
| 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 P Brahmani |
Vinayaka missions Kirupananda Variyar Medical College and Hospitals |
Room number 15,Department of Anesthesiology, Salem.
Salem
TAMIL NADU |
9972699415
brahmaniperisetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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 |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving valid informed consent
Patients with age 35 years and above of both gender with or without diabetes mellitus posted for surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patient refusal
Obvious anatomical neck deformity of face,hands,neck
Patients allergic to general anaesthetics
Co existing factors like rheumatoid arthritis
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and prevalence of difficult endotracheal intubation, compared diabetics and non diabetics |
From 0 mins of Premedication to 5 mins of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diagnostic performance of bedside airway prediction tests,use of adjunct or alternative techniques
|
From o mins of intaop to 5 mins after intubation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="1" |
|
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
|
This is an observational trial checking for difficulty in intubation from the time of premedication to the time of intubation.Diabetic patients are at higher risk for difficulty laryngoscopy and endotracheal intubation compared to non Diabetic patients ,primarily due to limited joint mobility syndrome from non enzymatic glycosylation of tissues ,which can affect Atlanto -occipital joint extension and neck mobility.diabetic specific signs like palm print sign,prayer sign .pre operative screening with diabetes specific tests is recommended for better anticipation in Diabetic patients undergoing intubation |