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CTRI Number  CTRI/2021/08/035715 [Registered on: 17/08/2021] Trial Registered Prospectively
Last Modified On: 18/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to correlate preoperative ultrasonographic airway assessment with laryngoscopic view in adult patients. 
Scientific Title of Study   Comparison between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients - A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jatin Lal 
Designation  Professor 
Affiliation  Pt. B. D. Sharma PGIMS, Rohtak 
Address  Dept of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9728265511  
Fax    
Email  dr.jatinlal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatin Lal 
Designation  Professor 
Affiliation  Pt. B. D. Sharma PGIMS, Rohtak 
Address  Dept of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9728265511  
Fax    
Email  dr.jatinlal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Isha Bodh 
Designation  Junior Resident 
Affiliation  Pt. B. D. Sharma PGIMS, Rohtak 
Address  Dept of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9654605295  
Fax    
Email  ibodh12@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesiology, Pt. B. D. Sharma PGIMS, Rohtak Haryana  
 
Primary Sponsor  
Name  Dept of Anaesthesiology Pt B D Sharma PGIMS Rohtak 
Address  Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana  
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 
Dr Jatin Lal  Pt. B. D. Sharma PGIMS, Rohtak 124001 Haryana   Department of Anaesthesiology
Rohtak
HARYANA 		 9728265511

dr.jatinlal@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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patents posted for elective surgery under general anaesthesia requiring endotracheal intubation. 
 
ExclusionCriteria 
Details  Patients:
1. Requiring rapid sequence induction
2. With cervical spine pathology
3. Requiring fibre optic tracheal intubation
4. Restricted mouth opening( <3cm) and edentulous
5. With anatomical deformity of face and neck which may lead to difficult ultrasound assessment
6. BMI >35 kilogram per square metre
7. History of obstructive sleep apnoea
8. Uncooperative patients
9. Pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the correlation between preoperative Ultrasonographic airway assessment of following parameters with laryngoscopic view (Cormack Lehane)
1. Ratio of depth of preepiglottic space (Pre-E) and distance from epiglottis to the midpoint of the distance between the vocal cords (E-VC)
2. Anterior soft tissue neck thickness at the level of hyoid (ANS-Hyoid) and vocal cords (ANS-VC) 		 1. Preoperative.
2. During laryngoscopy for endotracheal intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate physical parameters of airway assessment viz modified mallampati score, thyromental, hyomental, sternomental distances and neck mobility with laryngoscopic view ( Cormack Lehane)  1. Preoperative
2. During laryngoscopy for endotracheal intubation. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/08/2021 
Date of Study Completion (India) 25/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The present prospective, cross-sectional, observational, double blinded single arm study will be conducted in the department of Anaesthesiology and Critical care, Pt B. D. Sharma, PGIMS, Rohtak, in 110 patients of either sex aged 18-65 years posted for elective surgery under general anaesthesia requiring endotracheal intubation. The aim of the study is to assess the correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients. The primary objective is to correlate preoperative ultrasonographic airway assessment with laryngoscopic view (Cormack Lehane) with respect to following parameters:
1. Ratio of depth of preepiglottic space (Pre-E) and distance from epiglottis to the midpoint of the distance between the vocal cords (E-VC)
2.  Anterior soft tissue neck thickness at the level of hyoid (ANS-Hyoid) and vocal cords (ANS-VC).
The secondary objective is to correlate physical parameters of airway assessment viz modified mallampati score, thyromental, hyomental, sternomental distances and neck mobility with laryngoscopic view ( Cormack Lehane)
 
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