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CTRI Number  CTRI/2022/10/046337 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 07/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Prediction of difficult airway in patients using a simple bedside test called thyromental height test using digital depth caliper  
Scientific Title of Study   CORRELATION OF DIRECT LARYNGEAL VISUALISATION WITH THYROMENTAL HEIGHT TEST IN UNANTICPATED DIFFICULT AIRWAY PATIENTS”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNANDINI CV 
Designation  ASSISTANT PROFESSOR  
Affiliation  DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE
DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE
Bangalore
KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrNANDINI CV 
Designation  ASSISTANT PROFESSOR  
Affiliation  DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE
DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE

KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DrNANDINI CV 
Designation  ASSISTANT PROFESSOR  
Affiliation  DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE
DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, SHAMPURA, KADUGONDANAHALLI, BANGALORE

KARNATAKA
560045
India 
Phone  9535024072  
Fax    
Email  nandinivraj@yahoo.co.in  
 
Source of Monetary or Material Support  
DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  
 
Primary Sponsor  
Name  DrNANDINI CV 
Address  DEPARTMENT OF ANAESTHESIA,DR.B.R.AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SHAMPURA ROAD KADUGONDANAHALLI BANGALORE -560045 
Type of Sponsor  Other [SELF] 
 
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 
Dr NANDINI CV   DR BR AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANAESTHESIA DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL SHAMPURA BANGALORE
Bangalore
KARNATAKA 		 9535024072

drnandinivraj@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTUTION ETHICS COMMITTEE DR B R AMBEDKAR MEDICAL COLLEGE  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 50 years and
Patients with ASA- PS grade 1-2 
 
ExclusionCriteria 
Details  a) Patient refusal
b) Maxillofacial and neck deformity, trauma or surgery
c) Clinically anticipated difficult airway (requiring awake intubation)
d) BMI >35 kg/m2.
e) Pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To correlate Thyromental height test with ease of direct laryngeal visualization as assessed by Cormack-Lehane grading..
 		 Difficulties in visualization of the vocal cords during laryngoscopy and intubation, usually graded as Cormack &Lehane grade III and IV and classified as “difficult”
Grade I: Full view of the glottis.
Grade IIa: Partial view of the glottis is visible.
Grade IIb:Arytenoids or posterior part of the vocal cords only just visible.
Grade III: Only epiglottis is visible.
Grade IV: No glottis structures visible . 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate clinically mallampati grading, sternomental distance, thyromental distance with direct laryngeal visualization as assessed by Cormack Lehane grading.
2.To assess time taken for endotracheal intubation.
3.To correlate TMHT with the incidence of difficult intubation.
 		 Difficulties in visualization of the vocal cords during laryngoscopy and intubation, usually graded as Cormack &Lehane grade III and IV and classified as “difficult”
Grade I: Full view of the glottis.
Grade IIa: Partial view of the glottis is visible.
Grade IIb:Arytenoids or posterior part of the vocal cords only just visible.
Grade III: Only epiglottis is visible.
Grade IV: No glottis structures visible . 
 
Target Sample Size   Total Sample Size="261"
Sample Size from India="261" 
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)   14/10/2022 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Unanticipated difficult airway is a major concern for an anesthesiologist. The need to predict potentially difficult tracheal intubation with an accurate marker, even before laryngoscopy, has received more importance but with limited success .There is a need for a test, which is (a) quick and easy to perform; (b) is highly sensitive (so that majority of difficult cases can be identified); and (c) highly specific (so that false positive rate will be low when the test is used routinely). Any test devised should be easy to perform and interpret at the bedside. The TMHT is an easy-to-do and non-invasive test. The test is based on the height between the anterior border of the mentum and the thyroid cartilage .The aim of this study is to determine clinical performance and usefulness of the TMHT as a predictor of difficult intubation. Thus we plan to test the hypothesis that, decreased TMHT is associated with higher incidence of difficult laryngeal visualisation.

 
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