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CTRI Number  CTRI/2020/01/022820 [Registered on: 16/01/2020] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prediction of anticipation of difficulty of passing of tube in airway path for anaesthesia using sonography for measurement of tongue and distnce between different landmarks on neck and face 
Scientific Title of Study   Comparison of validity of a combination of Mallampati test with sternomental distance and thyromental distance and Mallampati test with ultrasound guided tongue thickness to predict difficult endotracheal intubation in adults 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIl  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prerana Nirav Shah 
Designation  Professor (Additional) 
Affiliation  GSMC KEMH 
Address  Department of Anaesthesiology GSMC KEMH Parel Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027   
Fax    
Email  PPS@KEM.EDU  
 
Details of Contact Person
Scientific Query  
Name  Dr ARYADEVI A S 
Designation  RESIDENT  
Affiliation  GSMC KEMH 
Address  DEPARTMENT OF ANAESTHESIOLOGY GSMC KEMH PAREL MUMBAI MAHARASHTRA 400012 INDIA Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9496779844  
Fax    
Email  ARYADEVIMARAR1067@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  Dr ARYADEVI A S 
Designation  RESIDENT  
Affiliation  GSMC KEMH 
Address  DEPARTMENT OF ANAESTHESIOLOGY GSMC KEMH PAREL MUMBAI MAHARASHTRA 400012 INDIA Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9496779844  
Fax    
Email  ARYADEVIMARAR1067@GMAIL.COM  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, 1st floor, GSMC KEMH Mumbai 400012  
 
Primary Sponsor  
Name  GSMC KEMH 
Address  Department of Anaesthesiology 1st Floor old hospital building Parel Mumbai 400012  
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 ARYADEVI A S  GSMC KEMH  DEPARTMENT OF ANAESTHESIOLOGY GSMC KEMH PAREL MUMBAI MAHARASHTRA 400012 INDIA
Mumbai
MAHARASHTRA 		 9496779844

aryadevirmarar1067@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC-II   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age:18-65 years
2)Patients of both genders
3)Body mass index <30 kg/m2
4)Patients undergoing all kind of elective surgeries under general anaesthesia requiring endotracheal intubation
5) American Society of Anaesthesiologists grade I and II
 
 
ExclusionCriteria 
Details  1)Patients not willing to participate in study.
2)Patients with insitu endotracheal tube.
3)Pregnant women
4)Patients requiring rapid sequence intubation.
5)Patients with restricted mouth opening of less than 2 centimetres or thyromental joint immobility in whom laryngoscope cannot be inserted and hence Cormack-Lehane grading not possible.
6)Patients with swelling, scars, contractures in front of neck.
7)Patients with cervical spine pathology, in whom neck extension is difficult.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the validity to predict difficulty in endotracheal intubation with a combination of Mallampati test with thyromental distance and sternomental distance and Mallampati test with ultrasound guided tongue thickness.  day prior to surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of laryngoscopy (in seconds)
Duration of intubation (in seconds)
Details of manoeuvres or use of advanced equipments during difficult intubation.
 		 On day of surgery 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Unanticipated difficult endotracheal intubation remains a challenge in anaesthesia. There are many parameters to predict difficult endotracheal intubation. By combining several parameters which predicting difficult endotracheal intubation, diagnostic accuracy of difficult endotracheal intubation can be improved.  Ultrasonography being a non-invasive and inexpensive method, we can use it for measuring tongue thickness which is a predictor of difficult endotracheal intubation. In this study we will use Mallampati test, Sternomental distance, thyromental distance and ultrasound guided tongue thickness measurement to evaluate patient’s airway and these will correlate with Cormack lehane grade visualised at the time of intubation. This prospective and observational study will be done in 165 patients of age between 18 and 65 years posted for any type of elective surgery undergoing general anaesthesia requiring endotracheal intubation. The aim of the study is to compare the validity of a combination of mallampati test with sternomental and thyromental distance and mallampati test with ultrasound guided tongue thickness to predict difficult endotracheal intubation in adults. In addition, duration of laryngoscopy, duration of intubation and number of attempts of intubation shall also be noted.

 
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