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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
Details   
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.sgmehandale@gmail.com].

  6. 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.

  7. 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.

 
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