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CTRI Number  CTRI/2020/03/024324 [Registered on: 27/03/2020] Trial Registered Prospectively
Last Modified On: 24/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound examination of airway 
Scientific Title of Study   Ultrasound guided evaluation of airway in predicting difficult endotracheal intubation in an eastern Indian Hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anbesh Dash 
Designation  DNB trainee 
Affiliation  Tata Main Hospital 
Address  Department of Anaesthesiology Main Operation Theater Complex 2nd Floor, JGMH Building Tata Main Hospital C Road, Bistupur Jamshedpur

Purbi Singhbhum
JHARKHAND
831001
India 
Phone  06576641166  
Fax    
Email  anbesh1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhanu Pratap Swain 
Designation  Specialist 
Affiliation  Tata Main Hospital 
Address  Department of Anaesthesia Tata Main Hospital C- Road, Bistupur Jamshedpur

Purbi Singhbhum
JHARKHAND
831001
India 
Phone  9471519719  
Fax    
Email  bhanu_swain@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Bhanu Pratap Swain 
Designation  Specialist 
Affiliation  Tata Main Hospital 
Address  Department of Anaesthesia Tata Main Hospital C-Road, Bistupur Jamshedpur

Purbi Singhbhum
JHARKHAND
831001
India 
Phone  9471519719  
Fax    
Email  bhanu_swain@yahoo.co.in  
 
Source of Monetary or Material Support  
Tata Main Hospital C Road West, Northern Town Bistupur, Jamshedpur 831001 Jharkhand (IND) 
 
Primary Sponsor  
Name  Tata Main Hospital 
Address  C Road West, Northern Town Bistupur, Jamshedpur 831001 Jharkhand (IND) 
Type of Sponsor  Other [Industrial 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 Bhanu Pratap Swain  Tata Main Hospital  Department of Anaesthesiology C Road West, Northern Town Bistupur, Jamshedpur 831001 Jharkhand (IND)
Purbi Singhbhum
JHARKHAND 		 7763807235

bhanu_swain@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Main Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: G959||Disease of spinal cord, unspecified, (3) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (4) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (5) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, (6) ICD-10 Condition: N209||Urinary calculus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct Laryngoscopy  Direct Laryngoscopy for endotracheal intubation 
Comparator Agent  not applicable  not applicable 
Intervention  ultrasound examination of different airway parameters  Frequency of examination: Once; Route of Administration: Not applicable; Total Duration: Not applicable; Parameters measured: 1.Skin soft tissue thickness at level of Hyoid bone 2.Skin soft tissue thickness at level of vocal cords 3.Distance from skin to epiglottis midway 4. Ratio of the depth of the Pre-Epiglottic space to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of ASA Grade I to II
2. Patients undergoing surgery requiring General
Anaesthesia with endotracheal intubation
 
 
ExclusionCriteria 
Details  1. Patients requiring rapid sequence endotracheal
intubation.
2. Patients with cervical spine pathology
3. Patients with head and neck pathology,large
thyroid swelling
4. Uncooperative patients
 
 
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 sensitivity, specificity, positive predictive value and negative predictive value of ultrasonographic airway assessment parameters; Skin soft tissue thickness at level of Hyoid bone, Skin soft tissue thickness at level of vocal cords, distance from skin to epiglottis midway and ratio of the depth of the Pre-Epiglottic space to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC) for predicting a difficult airway.  1.ULtrasound examination of airway will be done before endotracheal intubation
2. Intubation Difficulty score (IDS) assessment will be done during laryngoscopy and intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To develop a scoring system for ultrasonographic airway assessment parameters, which best predicts a difficult airway.  Scoring system will be developed after analysis of data of all recruited patients 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   27/03/2020 
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="9"
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)?  

Brief Summary   Several pre-operative airway assessment methods exist to predict difficult airway, but unexpected difficult endotracheal intubation may occur. These assessment criteria are not often useful in uncooperative patients and unconscious patients.  Most of the airway assessment criteria are objective in nature and are therefore prone to inter-observer variability. Also, the Cormack Lehane grading doesn’t always correlate with pre-op airway assessment parameters. Hence, the diagnostic accuracy by the pre-operative assessment technique remains inadequate for predicting difficult endotracheal intubation and there is still search for a simple, yet non-invasive way to provide more accurate prediction  about difficult airway. There are limited literature available comparing airway ultrasound parameters with difficult airway scoring system based on observation using direct laryngoscopy. Besides that, there is no available literature regarding ultrasonographic soft tissue thickness parameters of neck as a part of preoperative airway assessment in patients admitted to an Eastern Indian hospital.
 Therefore present study has been taken up to determine utility of ultrasound based airway assessment in evaluating difficult airway in patients admitted to an eastern Indian hospital.  
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