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CTRI Number  CTRI/2022/02/040652 [Registered on: 28/02/2022] Trial Registered Prospectively
Last Modified On: 16/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Using Ultrasonography machine to predict the level of difficulty for intubation while giving general anaesthesia 
Scientific Title of Study   “Ultrasonographic evaluation of the Epiglottis position to predict difficult laryngoscopy -A prospective study”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathish Kumar Gnanadoss P 
Designation  Senior Resident 
Affiliation  B.J. Medical College, Ahmedabad 
Address  F3,Department of Anaesthesia, Civil hospital, Asarwa, Ahmedabad
F3,Department of Anaesthesia, Civil hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India 
Phone    
Fax    
Email  meetgnanadoss10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sathish Kumar Gnanadoss P 
Designation  Senior Resident 
Affiliation  B.J. Medical College, Ahmedabad 
Address  F3,Department of Anaesthesia, Civil hospital, Asarwa, Ahmedabad
F3,Department of Anaesthesia, Civil hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India 
Phone    
Fax    
Email  meetgnanadoss10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sathish Kumar Gnanadoss P 
Designation  Senior Resident 
Affiliation  B.J. Medical College, Ahmedabad 
Address  Room C408
PG hostel, Civil hospital, B.J. Medical college, Asarwa, Ahmedabad.

GUJARAT
380016
India 
Phone    
Fax    
Email  meetgnanadoss10@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Civil hospital, B.J. Medical college, Ahmedabad  
 
Primary Sponsor  
Name  Government supply 
Address  Department of Anaesthesia, Civil hospital, B.J. Medical college, Ahmedabad  
Type of Sponsor  Government medical college 
 
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 
Sathish Kumar Gnanadoss P  Orthopedic OT, ENT OT, Plastic OT, Gynecological OT, Neuro OT of Civil hospital, Ahmedabad   Department of Anaesthesia, Civil hospital, B.J. Medical college, Ahmedabad
Ahmadabad
GUJARAT 		 9629330050

meetgnanadoss10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B.J. Medical college & Civil Hospital, Ahmedabad  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 
Comparator Agent  corrrelation with modified Cormack lehene grading  modified Cormack lehene grading will be assessed during intubation while giving general anaesthesia 
Intervention  Ultrasonographic evaluation of epiglottis position.   USG assessment of the epiglottis position pre operatively before Intubating the patient for giving General anaesthesia using a USG system -sonosite with frequency array probe (13-6MHz). The following parameters will be measured: • Ratio of depth of pre epiglottic space to the distance from the epiglottis to the mid point of the space between the vocal cords- Pre-E/E-VC. • Angle between the epiglottis and glottis.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details 
ASA-PS grade 1,2,3,
Patients requiring endotracheal intubation & General anaesthesia for Elective surgery
 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. Patient undergoing emergency surgeries
3. Requiring Rapid sequence intubation[RSI]
4. Cervical spine instability
5. Restricted neck movements
6. Reduced mouth opening
7. Airway pathologies(maxillo-facial fractures, tumours etc)
8. Uncooperative patients
9. Pregnant patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pre-E/E-VC ratio and Angle between the epiglottis and glottis and correlation with
Modified cormack lehene gradding (ultrasonographic parameters) 		 Preoperatively before intubating the patient for giving General anaesthesia and during intubation 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/04/2022 
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="0"
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 - NO
Brief Summary  

This study is designed to analyze the efficacy of ultrasonography airway measurement of Angle between the epiglottis and glottis, The ratio of depth of pre epiglottic space(Pre -E) to distance from epiglottis to mid-point of distance between the vocal cords(E-VC) in predicting difficult laryngoscopy and to observe correlation with MCLS.

 
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