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CTRI Number  CTRI/2014/12/005306 [Registered on: 16/12/2014] Trial Registered Retrospectively
Last Modified On: 06/12/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of measurements of the face and neck on difficulty in seeing the larynx during anaesthesia in the Indian population 
Scientific Title of Study   Sternomental distance and sternomental displacement as predictors for difficult laryngoscopy in adult patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smita Prakash 
Designation  Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India 
Address  C - 17 HUDCO place
C - 17 HUDCO place
New Delhi
DELHI
110049
India 
Phone  09810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smita Prakash 
Designation  Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India 
Address  C - 17 HUDCO place
C - 17 HUDCO place
New Delhi
DELHI
110049
India 
Phone  09810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smita Prakash 
Designation  Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India 
Address  C - 17 HUDCO place
C - 17 HUDCO place
New Delhi
DELHI
110049
India 
Phone  09810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Source of Monetary or Material Support  
Safdarjang Hospital, New Delhi 
 
Primary Sponsor  
Name  Safdarjang Hospital 
Address  Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjang Hospital New Delhi-110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Smita Prakash  Department of Anaesthesia and Intensive Care  Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India
New Delhi
DELHI 
9810347125

drsunilprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Safdarjang Hospital and VMMC, New Delhi 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Difficult laryngoscopy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  observational study  Observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA physical status I- III adult patients scheduled for elective surgery under general anesthesia requiring tracheal intubation 
 
ExclusionCriteria 
Details  Patients with obvious malformation of the neck or face in whom tracheal intubation under general anesthesia would be contraindicated, inter incisor distance < 1.5cm, unstable cervical spine, and patients requiring rapid sequence induction.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)To determine the optimum threshold value of SMD for difficult laryngoscopy in the Indian population.
2) To determine the extent of SMD displacement that correlates with difficult laryngoscopy.
 
At induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the optimum threshold value of SMD for difficult intubation in the Indian population.  At induction of anaesthesia 
 
Target Sample Size   Total Sample Size="610"
Sample Size from India="610" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2012 
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   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Failed tracheal intubation can have potentially life threatening consequences. Several preoperative airway assessment tests have been suggested to predict difficult laryngoscopy. Sternomental distance (SMD) is an indicator of head and neck mobility and it has been suggested that SMD is the best single test for ruling out difficult intubation amongst forced protrusion of the mandible, inter incisor gap, modified Mallampati grade and thyromental distance (TMD).  Previous studies have addressed the correlation between SMD and difficult laryngoscopy. The cut-off point of SMD for difficult laryngoscopy was 12.5cm2 and 13.5 cm.

SMD is conventionally measured with the head extended on the neck (SMD extension).  A modification of measurement of SMD is the measurement obtained with the head in neutral position (SMD neutral). It has been suggested that a difference < 5 cm between SMD extension and SMD neutral, (henceforth referred to as sternomental displacement), is associated with a difficult laryngoscopy; 3 conversely, a sternomental displacement of more than 5 cm is indicative of easy laryngoscopy. 3    

SMD is likely to vary with patient size and proportion. The study hypothesis is that racial differences would affect SMD threshold values for predicting difficult laryngoscopy. The aim of the study is 1) to determine the optimum threshold value of SMD for difficult laryngoscopy (primary outcome measure) and also for difficult intubation in the Indian population; 2) to determine the extent of SMD displacement that correlates with difficult laryngoscopy.

 
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