| 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
|
|
|
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
|
|
|
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 |
|
|
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.
|