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CTRI Number  CTRI/2021/10/037568 [Registered on: 26/10/2021] Trial Registered Prospectively
Last Modified On: 25/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A comparison of ratio between shoulder and breast bone distance with existing airway predictors for difficult airway for intubation in Indian population 
Scientific Title of Study   A comparison of Acromio Axillary Suprasternal Notch Index with existing airway predictors for difficult airway in Indian population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pakhi Sharma 
Designation  post graduate 
Affiliation  kasturba medical college 
Address  department of anesthesiology kasturba medical college mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7030103537  
Fax    
Email  dr.pakhis@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Y V 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anesthesiology Kasturba Medical College Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7030103537  
Fax    
Email  sureshyv63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pakhi Sharma 
Designation  post graduate 
Affiliation  kasturba medical college 
Address  department of anesthesiology kasturba medical college mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7030103537  
Fax    
Email  dr.pakhis@gmail.com  
 
Source of Monetary or Material Support  
kasturba medical college 
 
Primary Sponsor  
Name  Dr Pakhi Sharma 
Address  Department of Anesthesiology Kasturba Medical College Mangalore 
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 Pakhi Sharma  Kasturba Medical College  Sixth floor OT Complex Department of Anesthesiology Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA 		 7030103537

dr.pakhis@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. ASA physical status I, II
2. Patient undergoing elective surgeries under General anesthesia requiring endotracheal intubation.
 
 
ExclusionCriteria 
Details  1.Consent not given.
2. Obvious anatomical abnormality of face, head, neck and shoulder.
3. Upper airway abnormality (e.g. tongue tumor, maxillofacial tumor or fracture)
4. Any head and neck surgery or radiation
5. Inability to open mouth
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Acromio Axillo Suprasternal notch Index
2. Modified Mallampati test
3. Inter incisor distance.
4. Upper lip bite test
5. Cormack and Lehane staging
 		 1. During pre anesthetic check up for point 1 to 4
2. During intubation (one day later) 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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)   29/10/2021 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
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 (Others) - 

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 22-09-2022 and end date provided 05-02-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study is aimed to evaluate the accuracy of Acromio Axillo Suprasternal Notch Index and compare it with inter incisor distance, Upper Lip Bite Test and Mallampati score for assessing Difficult Visualisation of Larynx in patients under General anesthesia.

 
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