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CTRI Number  CTRI/2019/11/022164 [Registered on: 27/11/2019] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   This study is designed to know whether by taking measurements of different external features of mouth and neck would help in predicting old patients whose vocal chords could be difficult to visualize under general anaesthesia. 
Scientific Title of Study   Comparison of various predictors of difficult airway in geriatric patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratibha Panjiar  
Designation  Assistant Professor  
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Critical care Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi, 110062, India

South
DELHI
110062
India 
Phone  9311657822  
Fax    
Email  pratibha.panjiar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pratibha Panjiar  
Designation  Assistant Professor  
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Critical care Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi, 110062, India

South
DELHI
110062
India 
Phone  9311657822  
Fax    
Email  pratibha.panjiar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pratibha Panjiar  
Designation  Assistant Professor  
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Department of Anaesthesiology and Critical care Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi, 110062, India

South
DELHI
110062
India 
Phone  9311657822  
Fax    
Email  pratibha.panjiar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Hamdard Institute of Medical Sciences and Research, New Delhi  
 
Primary Sponsor  
Name  Hamdard Institute of Medical Sciences and Research  
Address  Hamdard Institute of Medical Sciences and Research Jamia Hamdard New Delhi  
Type of Sponsor  Research institution and hospital 
 
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 
Pratibha Panjiar   Hamdard Institute of Medical Sciences and Research   Department of Anaesthesiology Preanesthetic check up clinic, 7 th floor Block B Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi
South
DELHI 		 9311657822

pratibha.panjiar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient above 65 year of age, ASA grade I and II, of any sex posted for surgery under general anaesthesia with endotracheal intubation  
 
ExclusionCriteria 
Details  Patients posted for Emergency surgery, patients with neck burn contracture, midline neck swelling, oral surgery, uncooperative patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine validity indexes for mallampatti grading, interincisor gap, thyromental distance, sternomental distance, upper lip bite test, ratio of height to thyromental distance, and thyromental height test for predicting difficult laryngoscopy in geriatric patients.  preoperative ( during preanaesthetic check up), intraoperative ( intubation) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the predictive role of basic physical characteristics ( weight, height, BMI) and dentition, in predicting difficult airway in geriatric patients   preoperative ( during preanaesthetic check up), intraoperative ( intubation) 
To determine the frequency of difficult endotracheal intubation in elderly patients.  Intraoperative ( intubation) 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   14/01/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Unanticipated difficult airway can result in significant morbidity and mortality to the patients. So preoperative assessment of patient’ airway is very crucial for anaesthesiologists. The elderly population is gradually increasing. As a result the importance of evaluating the difficulty in the elderly has been increasing. Although the evidence is still limited previous studies have shown the elder patients predisposing to have difficult airway. Difficult endotracheal intubation is expected in geriatric patients due to degenerative changes such as dental loss and head and neck changes. Results of this study will help us in evaluating validity indexes of common airway predictors of difficult airway in elderly patients. Accurate  prediction of difficult airway in geriatric patients can reduce the morbidity and mortality associated with airway management as these patients are already at increased risk. 
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