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CTRI Number  CTRI/2026/02/103468 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective study 
Study Design  Other 
Public Title of Study   Grading the ease of intubation using AI 
Scientific Title of Study   Evaluating the efficiency of artificial intelligence in accurately classifying mallampatti score 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LILLIA JOE 
Designation  JUNIOR RESIDENT  
Affiliation  Amrita institute of medical sciences  
Address  Department of anaesthesia and critical care Amrita institute of medical sciences Amrita lane Elamakkara P.O.ponekkara, kochi

Ernakulam
KERALA
682041
India 
Phone  7012521393  
Fax    
Email  lillia.erinjeri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jerry paul 
Designation  Professor  
Affiliation  Amrita institute of medical sciences  
Address  Department of anaesthesia and critical care Amrita institute of medical sciences Amrita lane Elamakkara P.O.ponekkara, Edapally kochi

Ernakulam
KERALA
682041
India 
Phone  9048699161  
Fax    
Email  drjerrypaul@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zubair umer Mohamed  
Designation  Associate professor 
Affiliation  Amrita institute of medical sciences  
Address  Department of anesthesia and critical care Amrita institute of medical sciences Amrita lane Elamakkara P.O.ponekkara, Edapally kochi

Ernakulam
KERALA
682041
India 
Phone  9496038812  
Fax    
Email  Zubairumer@gmail.com  
 
Source of Monetary or Material Support  
Amrita institute of medical sciences Aims ponekkarapo Edapally,kochi,kerala 682041 
Department of health research(DHR),HRD scheme 1sr floor,IRCS Building 1,Red cross,newdelhi-110001 India 
 
Primary Sponsor  
Name  Lillia Joe 
Address  Department of Anaesthesia and critical care Amrita institute of medical sciences Elamakara,kochi ponekkara 682041 
Type of Sponsor  Other [Self] 
 
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 Zubair Mohamed   Amrita institute of medical sciences   PAC clinic Department of anaesthesia and critical care Elamakkara, kochi ponekkara Edappally po Kerala 682041
Ernakulam
KERALA 
9496038812

zubairumer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Amrita school of Medicine   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers who consent for the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Anyone above 18yrs to 85yrs willing to participate  
 
ExclusionCriteria 
Details  Below 18 yrs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the performance of the AI model against expert anaesthesiologist in assessing mallampati score  52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To develop an AI based model that can accurately classify mallampatti scores from images of the patients oral cavity  52 weeks 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   16/02/2026 
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="0"
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   This preliminary research protocol outlines a prospective study conducted in the Department of Anaesthesia and Critical Care at Amrita Institute of Medical Sciences to evaluate the efficiency of Artificial Intelligence (AI) in accurately classifying the Mallampatti score. The primary objective is to compare the performance of an AI-based model with expert anaesthesiologists in assessing Mallampatti classification, while the secondary objective focuses on developing an automated AI system capable of classifying Mallampatti scores from oral cavity images.



The study is based on the rationale that traditional Mallampatti assessment is subjective and prone to inter-observer variability. By using deep learning techniques, particularly Convolutional Neural Networks (CNNs), the study aims to improve objectivity, accuracy, and consistency in airway assessment. A dataset of approximately 800 annotated oral cavity images will be collected from adult patients, pre-processed, and used to train and validate AI models including ResNet-50 and MobileNetV2. Model performance will be evaluated using accuracy, precision, recall, F1-score, and confusion matrices.



Anticipated outcomes include improved prediction of difficult airways, enhanced clinical decision-making, streamlined preoperative workflows, and potential educational benefits for training clinicians. Ethical considerations such as informed consent, data anonymization, and bias mitigation are emphasized. Overall, the study seeks to establish AI as a reliable and clinically relevant tool for airway assessment in anaesthesiology.


 
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