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CTRI Number  CTRI/2024/12/078097 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   difficult airway prediction using conventional methods vs mobile app (ATAM) 
Scientific Title of Study   Comparison of airway assesment by conventional methods with mobile based application for morbidly obese patient. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruv Sugandhi 
Designation  Junior Resident 
Affiliation  Sri Aurobindo Institute of Medical Sciences And PG Institute 
Address  Department of Anaesthesia 5th floor, OT Complex
SAIMS Capmus, Indore-Ujjain Highway
Indore
MADHYA PRADESH
453555
India 
Phone  9730089890  
Fax    
Email  dr.dhruvsugandhi@aol.com  
 
Details of Contact Person
Scientific Query  
Name  Atul Dixit 
Designation  Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences And PG Institute 
Address  Sri Aurobindo Institute of Medical Sciences And PG Institute 5th Floor OT Complex
Indore-Ujjain state Highway, Bhawarsala, Indore
Indore
MADHYA PRADESH
453555
India 
Phone  9826040001  
Fax    
Email  lutatixid@duck.com  
 
Details of Contact Person
Public Query  
Name  Atul Dixit 
Designation  Professor 
Affiliation  Sri Aurobindo Institute of Medical Sciences And PG Institute 
Address  Sri Aurobindo Institute of Medical Sciences And PG Institute, 5th Floor OT Complex
Indore-Ujjain State Highway, Bhawarsala, Indore
Indore
MADHYA PRADESH
453555
India 
Phone  9826040001  
Fax    
Email  lutatixid@duck.com  
 
Source of Monetary or Material Support  
Sri Aurobindo institute of medical science and PG Institute, Indore, MP  
 
Primary Sponsor  
Name  Dhruv Sugandhi 
Address  Sri Aurobindo Institute of Medical Sciences, Indore-Ujjain State Highway Bhawarsala Indore 
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 
Dhruv Sugandhi  SRI AUROBINDO INSTITUTE OF MEDICAL SCIENCES AND PG INSTITUTE  Sri Aurobindo Institute of Medical Sciences and PG Institute, Indore_Ujjain State Highway, Bhawarsala, Indore
Indore
MADHYA PRADESH 		 9730089890

dr.dhruvsugandhi@aol.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Aurobindo Institute of Medical Sciences and PG Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E66||Overweight and obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  use of Airway Triage Application Method (ATAM)  using a mobile based application ATAM to assess and predict difficult airway for patients undergoing bariatric surgeries. 
Comparator Agent  using Conventional Method  using conventional methods to assess and predict difficult airway for patients undergoing bariatric surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA grade 2 and above 
 
ExclusionCriteria 
Details  Patient who refuse to participate in the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To identify advantages of mobile based application over traditional/conventional methods in predicting difficult airway for intubation  Before Intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative airway assessment of difficult airway airway is done by noting following parameters-
 		 At the time of intubation 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   23/12/2024 
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)
Modification(s)  		 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   Aim- To compare airway assessment by conventional methods with a mobile based application in predicting need for airway aid during intubation for morbidly obese patients.

Objective- To identify advantages of mobile based application over traditional/conventional methods in predicting difficult airway for intubation. 

Study design- it is a prospective observational study.

Sample size- 300 patients who are planned for elective bariatric surgery.

Inclusion criteria-
  1.  Age > 18years
  2. BMI > 35 Kg/m2
  3. ASA grade 2 and above
Exclusion criteria-
  1. Age >70years
  2. Patient who refuse to take participate in study.


Methodology- 
Airway assessment will be done via both conventional methods and via using mobile app ATAM ( Airway Triage Application Method ).
Conventional methods assessed via noting- 

1. Mallampati Grade 
2. Neck mobility 
3. Mouth opening
Intraoperative airway assessment of difficult airway airway is done by noting following parameters- 
  • Use of oropharyngeal airway
  • Needing assistance in BMV
  • Requiring BURP
  • Using Bougie
  • Failed 1st attempt or need expert guidance or even direct intervention from the expert.
Conclusion- The findings could standardise airway assessment protocols reducing perioperative complications by predicting difficult airway and improving patient safety.
 
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