FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/11/016352 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 14/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound for studying the upper part of the breathing system to predict difficulty in seeing the opening of the voice box during administration of general anaesthesia 
Scientific Title of Study   Sonographic upper airway evaluation for prediction of 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  Dr Jamuna M 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9632187634  
Fax    
Email  jamuna.m.g@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejesh CA 
Designation  Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejesh CA 
Designation  Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College and Hospitals New BEL road MSRIT post Bangalore-560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical college and Hospitals 
Address  New BEL Road MSRIT Post Bangalore 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Jamuna M  Department of Anaesthesiology MS Ramaiah Medical College Bangalore 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jamuna M  MS Ramaiah Medical Teaching Hospital  Department of Anaesthesiology 2nd floor MSRMTH New BEL Road
Bangalore
KARNATAKA 
9632187634

jamuna.m.g@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramaiah Medical College and Hospitals  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 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients scheduled to undergo elective surgery under general anaesthesia categorised as American Society of Anaesthesiologists (ASA) Grade I and II
 
 
ExclusionCriteria 
Details  Patients with:
Interincisor gap < 3cm
Edentulous patients / partial dentition
Maxillofacial abnormalities
Restricted neck movements
Cervical tumors or goiter
Oropharyngeal pathology
Cervical spine instability
Pregnancy
History of difficult laryngoscopy or intubation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prediction of difficult laryngoscopy in terms of Cormack Lehane Grading system  During laryngoscopy five minutes after induction of general anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="226"
Sample Size from India="226" 
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)   15/12/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Airway management is one of the critical skills mastered by anaesthesiologists and it is their prime responsibility. Suboptimal airway management is a major cause of patient morbidity and mortality. Unanticipated difficult laryngoscopy and intubation remains one of the most important concerns and challenges in routine anaesthesia practice. Accurate airway assessment may reduce the number of unanticipated difficult laryngoscopy and intubation, as well as enable modification of initial airway management plan. The currently employed routine clinical airway assessment parameters when used alone or in combination are however unable to predict difficult laryngoscopy and intubation with satisfactory sensitivity and specificity.

Ultrasound machines are now widely available in operating rooms and is becoming an inherent part of anaesthesiologist’s armamentarium for vascular access and regional anaesthesia. Ultrasound is safe, non-invasive, portable, easily reproducible  and gives real time images. Sonography has been used for airway assessment and has been evolving as a useful tool for this purpose. Encouraging results have been obtained in few studies utilising the sonographic parameters for assessment of airway. However, there are no established standard sonographic parameters to predict difficult laryngoscopy. Hence, the present study is designed to evaluate any correlation between sonographically assessed parameters and the grade of difficulty at direct laryngoscopy.

 
Close