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CTRI Number  CTRI/2016/09/007313 [Registered on: 27/09/2016] Trial Registered Prospectively
Last Modified On: 28/01/2019
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 adults 
Scientific Title of Study   Evaluation of thyromental height, ratio of height to thyromental distance and thyromental distance as predictors of difficult laryngoscopy (and difficult intubation) 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  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India 
Address  C - 17 HUDCO place
Safdarjung Hospital, New Delhi 110029
South
DELHI
110049
India 
Phone  09810347125  
Fax  26163072  
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smita Prakash 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India 
Address  C - 17 HUDCO place
Safdarjung Hospital, New Delhi 110029
South
DELHI
110049
India 
Phone  09810347125  
Fax  26163072  
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smita Prakash 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India 
Address  C - 17 HUDCO place
Safdarjung Hospital, New Delhi 110029
South
DELHI
110049
India 
Phone  09810347125  
Fax  26163072  
Email  drsunilprakash@gmail.com  
 
Source of Monetary or Material Support  
Safdarjung Hospital, New Delhi 110029 
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College, New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Prakash  Safdarjung Hospital  Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029
South
DELHI 
09810347125

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
Modification(s)  
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  American Society of Anaesthesiologists physical status grade I or II adult patients, scheduled to undergo elective surgery under general anaesthesia with tracheal intubation. 
 
ExclusionCriteria 
Details  1. Patients with obvious abnormality of the airway requiring awake tracheal intubation
2. Post burn contracture neck, neck swelling
3. Inter‑incisor distance <2.5 cm
4. Patients at increased risk of aspiration
5. Unstable cervical spine
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the prediction index (cut-off value) and validity indices for thyromental height   At time of laryngoscopy and intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the validity indices for ratio of height to thyromental distance and thyromental distance for prediction of difficult laryngoscopy in adult patients.
2.To compare the thyromental height, ratio of height to thyromental distance and thyromental distance as predictors of difficult laryngoscopy in adult patients
 
At time of laryngoscopy and intubation 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/11/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Unexpected difficult laryngoscopy (DL) or intubation or failed tracheal intubation is an important aetiological factor in anaesthesia related morbidity and mortality. Several anthropometric measurements have been proposed to identify potentially difficult airways. Amongst these, the thyromental distance (TMD) has been widely used in the preoperative airway evaluation. The sensitivity and specificity of TMD as a predictor for difficult laryngoscopy is low and its role as a predictive test is debatable.  As TMD will vary with patient size, the ratio of height to TMD (RHTMD) may have a better predictive value than TMD alone, as the TMD cut-off value will be adjusted for patient size.   

The thyromental height (the height between the anterior borders of the mentum and thyroid cartilage with the patient in supine position and mouth closed) has been suggested as predictor of difficult laryngoscopy.  

The study hypothesis is that the height between the anterior borders of the mentum and thyroid cartilage, the thyromental height, can be a predictor of difficult laryngoscopy. The research question is to evaluate and compare the thyromental height, ratio of height to thyromental distance and thyromental distance for prediction of difficult laryngoscopy in adult patients undergoing elective surgery under general anaesthesia. The primary outcome measure is calculation of the prediction index (cut off value) and validity indices for the thyromental height.  

 
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