| CTRI Number |
CTRI/2021/05/033323 [Registered on: 03/05/2021] Trial Registered Prospectively |
| Last Modified On: |
01/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Designing an Automated System to Predict the Cases with Difficulties in Securing the Airway Using Machine Learning Algorithms and Image Processing |
|
Scientific Title of Study
|
Prediction of difficult airway management cases using machine learning and image processing techniques. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRIPADA G MEHENDALE |
| Designation |
Professor and Head |
| Affiliation |
KSHEMA Nitte University |
| Address |
Lakshmi Keshav 4th Cross Shivbag Mangaluru Department of Anaesthesiology and Critical Care K S Hegde Medical Academy Nitte DU Deralakatte Mangaluru Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9448384310 |
| Fax |
|
| Email |
sripadamehandale@nitte.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
SRIPADA G MEHENDALE |
| Designation |
Professor and Head |
| Affiliation |
KSHEMA Nitte University |
| Address |
Lakshmi Keshav 4th Cross Shivbag Mangaluru Department of Anaesthesiology and Critical Care K S Hegde Medical Academy Nitte DU Deralakatte Mangaluru
KARNATAKA 575002 India |
| Phone |
9448384310 |
| Fax |
|
| Email |
sripadamehandale@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
SRIPADA G MEHENDALE |
| Designation |
Professor and Head |
| Affiliation |
KSHEMA Nitte University |
| Address |
Lakshmi Keshav 4th Cross Shivbag Mangaluru Department of Anaesthesiology and Critical Care K S Hegde Medical Academy Nitte DU Deralakatte Mangaluru Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9448384310 |
| Fax |
|
| Email |
sripadamehandale@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte University
Deralakatte
Mangaluru
Dakshina Kannda
Karnataka
India |
| University at Baffalo, 12 Capen Hall Buffalo, NY 14260 (716) 645-2000 www.buffalo.edu.
New York
USA |
|
|
Primary Sponsor
|
| Name |
Dr Sripada Mehandale |
| Address |
Professor and Head
Department of Anaesthesiology and Critical Care
K S Hegde Medical Academy
Deralakatte
Mangaluru
Dakshina Kannada
Karnataka
India |
| Type of Sponsor |
Other [] |
|
|
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 Sripda G Mehandale |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology KS Hegde Medical Academy
Nitte University
Deralakatte
Mangaluru
Dakshina Kannada KARNATAKA |
9448384310
sripadamehandale@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee Nitte |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing general anaesthesia for elective surgical procedure |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Developing automated system using machine learning to predict the patients with difficulty in airway management. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To predict difiiculty in mask ventilation
To predict difficulty in supraglottic airway insertion
To Predict difficulty in laryngoscopy
To predict difficulty in endotracheal intubation
|
Six months |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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)
|
10/05/2021 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.sgmehandale@gmail.com].
- For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Airway management poses challenges of oxygenation cannot be maintained by either face mask ventilation, using a supraglottic device, endotracheal intubation or surgical airway (e.g., tracheostomy), when patient looses consciousness or breathing is compromised due to any reason. however, there is no single predictive test to anticipate such difficulties with maximum certainity as the difficult airway is multi factorial. If a system can be developed using artificial intelligence, that is machine learning using image processing, such situations can be instantly diagnosed, anticipated, managed correctly without any damages to the patient. Hypothesis: Incorporating the airway assessment tools with logic into an app that can
accurately predict difficult airway in unanticipated cases will help in
accurately predicting and managing difficult airway. AIM
To develop automated system using machine learning to predict the patients
with difficulty in airway management.
OBJECTIVES
Primary
objective:
To design an
automated system using machine learning algorithms to predict the difficulty in
managing airway.
Secondary
objectives:
To predict difiiculty in mask ventilation
To predict difficulty in supraglottic airway insertion
To Predict difficulty in laryngoscopy
To predict difficulty in endotracheal intubation
Compare them with actual clinical outcome Here we are intending to recruit 250 patients undergoing elective surgeries. Record their airway parameters, take frontal and profile pictures of head and neck, record the outcomes of airway management (mask ventilation, laryngoscopy, use of supraglottic airway, endotracheal intubation etc.) then compare the outcome with the airway indices, form an algorithm to predict difficulty in managing airway, process the images to arrive at predictors of difficulty in airway management. Thus, finally using machine learning launch an app which can predict difficulty in any of the above said parameters, soon after taking photographs in above said views with clinically useful accuracy. |