| CTRI Number |
CTRI/2026/01/101756 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A simple hand print test to help predict difficulty in placing a breathing tube during surgery in people with diabetes |
|
Scientific Title of Study
|
Evaluation of Palm Print Sign for Predicting Difficult Laryngoscopy in Diabetic Patients: A Comparative Study with Standard Airway Assessment Tests |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh Kumar K |
| Designation |
Pg Scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM Medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.
Chennai TAMIL NADU 603203 India |
| Phone |
8754352322 |
| Fax |
|
| Email |
dk4156@srmist.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr G Mirunalini |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM Medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.
Chennai TAMIL NADU 603203 India |
| Phone |
9486131643 |
| Fax |
|
| Email |
mirunalg@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr G Mirunalini |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM Medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu.
Chennai TAMIL NADU 603203 India |
| Phone |
9486131643 |
| Fax |
|
| Email |
mirunalg@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM Medical college Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu 603203, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G Mirunalini |
SRM Medical College Hospital |
Room No:D4 23,4th floor, D block Extension, Department of Anesthesia, SRM Medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, TamilNadu 603203, India. Chennai TAMIL NADU |
9486131643
mirunalg@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Type I and II diabetic mellitus.
2.Patients scheduled for elective surgery under GA with endotracheal intubation.
3.Patients with ASA I , II and III. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patients with trauma affecting airway anatomy.
3.Patients with cervical spine injury.
4.Patients with Abnormal neck anatomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of Palm Print Sign for prediction of difficult laryngoscopy, assessed by sensitivity, specificity, positive predictive value and negative predictive value using Cormack–Lehane grade as a standard reference tool. |
At the time of laryngoscopy during induction of general anaesthesia (intra-operative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of predictive accuracy (sensitivity, specificity and agreement) of Palm Print Sign with Mallampati classification, thyromental distance and degree of head extension for predicting difficult laryngoscopy. |
Pre-operative airway assessment and intra-operative laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="303" Sample Size from India="303"
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)
|
18/02/2026 |
| 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
|
Difficult laryngoscopy is more common in patients with diabetes mellitus due to limited joint mobility. Early identification of difficult airway helps in planning safer anaesthesia. The palm print sign is a simple, non-invasive bedside test that reflects joint stiffness and may predict difficult laryngoscopy. This is a prospective observational comparative study conducted in the Department of Anaesthesiology, SRM Medical College Hospital and Research Centre. Adult diabetic patients scheduled for surgery under general anaesthesia with endotracheal intubation will be included after informed consent. Pre-operative airway assessment will be done using palm print sign, Mallampati classification, thyromental distance and degree of head extension. During induction of anaesthesia, direct laryngoscopy will be performed by an anaesthesiologist blinded to pre-operative assessment, and laryngeal view will be graded using Cormack–Lehane classification as the reference standard. The primary outcome is to assess the diagnostic accuracy of palm print sign in predicting difficult laryngoscopy. Secondary outcomes include comparison with other airway assessment tests and agreement with Cormack–Lehane grading. |