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CTRI Number  CTRI/2021/06/034008 [Registered on: 04/06/2021] Trial Registered Prospectively
Last Modified On: 02/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To compare ultrasound scanning windpipe measurements with routine clinical assessment of windpipe measurements in identifying the difficulty in passing the tube in windpipe for general anaesthesia  
Scientific Title of Study   A correlation of ultrasonography versus clinically measured airway parameters in predicting difficult laryngoscopy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SIVA V 
Designation  Junior Resident 
Affiliation  Kasturba Medical College  
Address  Department of Anaesthesiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9840279237  
Fax    
Email  sivavimal1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Eeshwar M V 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9740122272  
Fax    
Email  eeshwar.kmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shaji Mathew 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Anaesthesiology Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449388791  
Fax    
Email  shajimanipal@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Manipal Academy of Higher Education, Manipal, Udupi, Karnataka. 576104  
Type of Sponsor  Private 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 
SIVA V  Kasturba Medical College  Department of Anaesthesiology, Main OT Complex, Manipal.
Udupi
KARNATAKA 		 9840279237

sivavimal1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  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  70.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery under general anaesthesia with endotracheal intubation .

patients belonging to American society of Anaesthesiologists , physical status I, II , III aged between 18 to 70 years . 
 
ExclusionCriteria 
Details  Patient refusal to participate in the study
Age less than 18 years
Preoperative anticipated difficult airway
Pregnant women
Patient with joint diseases involving TMJ and Cervical spine
Patient with laryngeal tumors 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the prediction of difficult airway by use of ultrasound guided measurements versus routine assessment of clinical airway parameters like
1.Thyro mental distance
2.Modified Mallampati score
3.Ratio of height to thyromental distance. 		 Outcome will be assessed at the time of baseline clinical assessment of airway and immediately at the time of intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To find the correlation between ratio oh height to thyromental distance and to predict a cut off value of skin to epiglottis thickness in our patient population.   Outcome will be assessed at the time of baseline clinical assessment of airway and immediately at the time of intubation 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   18/06/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published in any national or international journals 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Unanticipated difficult airway still remains a challenge to anaesthetist , my aim of the study is to compare ultrasound guided airway parameters such as preepiglottic space thickness , skin to epiglottis distance and comparing this with the routine airway assessment with clinical parameters such as thyromental distance , modified mallampati score and  ratio of height to thyromental distance in predicting difficult laryngoscopy in patients undergoing elective surgeries under general anaesthesia with endotracheal intubation and to predict a cutoff value of skin to epiglottis thickness in our patient population. 
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