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CTRI Number  CTRI/2024/09/073593 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   comparison between two airway examination methods for predicting difficult airway . 
Scientific Title of Study   Comparison of Simplified Airway Risk Index(SARI) and Difficult Airway Evaluation with Sonography(DARES) Protocol in predicting difficult laryngoscopy A Prospective Observational study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr swarnapriya Naik 
Designation  Junior Resident Academic 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  All India Institute of Medical Sciences, Department of Anaesthesiology and Critical Care, sijua ,Bhubaneswar , Odisha .

Khordha
ORISSA
751019
India 
Phone  9938517906  
Fax    
Email  swarnapnaik@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya Samal 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  All India Institute of Medical Science, Department of Anaesthesiology and Critical Care, sijua , Bhubaneswar, Odisha .

Khordha
ORISSA
751019
India 
Phone  7978041867  
Fax    
Email  samalsoumya11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Samal 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  All India Institute of Medical Science, Department of Anaesthesiology and Critical Care, sijua , Bhubaneswar, Odisha .

Khordha
ORISSA
751019
India 
Phone  7978041867  
Fax    
Email  samalsoumya11@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bhubaneswar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences , Bhubaneswar  
Address  AIIMS , Bhubaneswar , sijua , 751019 , Odisha 
Type of Sponsor  Research institution and hospital 
 
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 swarnapriya naik  Aiims indoor wards of surgical departments and in the OT pre-operating area  All India Institute of Medical Sciences, Bhubaneswar , Sijua , 751019, Odisha
Khordha
ORISSA 		 9938517906

swarnapnaik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Bhubaneswar  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) ASA grade I ,II ,III patients .
2) Age – 18 to 60 years
3) Posted for elective surgeries under General anaesthesia
 
 
ExclusionCriteria 
Details  1. Anatomical airway abnormality.
2. Restricted neck movement.
3. Skin infection over neck region.
4. Pregnant ladies.
5. Patient requiring rapid sequence intubation or scheduled for awake fibreoptic tracheal intubation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the incidence of difficult laryngoscopy using SARI and DARES protocol.   At the end of study trial. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the sensitivity, specificity, positive predictive value and negative predictive value of SARI and DARES protocol.  At the end of study trial. 
To determine the diagnostic accuracy of SARI and DARES protocol in predicting difficult laryngoscopy.  At the end of study trail. 
To observe gender based differences SARI and DARES protocol in predicting difficult laryngoscopy.  At the end of study trial. 
To find out the percentage of each parameters of DARES protocol in predicting difficult laryngoscopy  At the end of study trial. 
 
Target Sample Size   Total Sample Size="410"
Sample Size from India="410" 
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)   12/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Incidence of unanticipated difficult laryngoscopy is 9.7%. Group indices are proven to be better than individual indices in predicting difficult airway , Simplified Airway Risk Index (SARI) is having highest diagnostic accuracy of 90 % among all other group indices . Point of care ultrasound is an emerging tool in predicting and managing difficult airway. Difficult Airway Evaluation with Sonography (DARES) Protocol has been developed  to  predict difficult laryngoscopy. However, further study is required to find out whether the  DARES protocol can alone be used in predicting difficult laryngoscopy by comparing the diagnostic accuracy with SARI. 
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