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
|
|
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
|
|
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. |