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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  
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 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  
Status 
Not Applicable 
 
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.

 
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