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CTRI Number  CTRI/2024/04/065487 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 07/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective, comparative, double blinded 
Study Design  Other 
Public Title of Study   A study of prediction of difficult visualization of larynx by comparing airway assessement tests. 
Scientific Title of Study   Comparison of newer airway assessement tests- upper lip bite test (ULBT), ratio of height to thyromental distance (RHTMD), thyromental height test (TMHT), and acromio-axillo suprasternal notch index(AASI) for visualization of larynx in geriatric population: A prospective, observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer


RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Khare 
Designation  Senior Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anaesthesiology, new OT, 1st floor, JLN hospital, kalabagh, Ajmer


RAJASTHAN
305001
India 
Phone  9414306114  
Fax    
Email  arvindkhare68@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology,New OT, 1st floor, JLN Hospital,Kalabagh, Ajmer, Rajasthan 305001 
 
Primary Sponsor  
Name  JLN medical college  
Address  New OT, 1st floor,Kalabagh, Ajmer, Rajathan,305001 
Type of Sponsor  Government medical college 
 
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 Pankaj Swami  JLN medical college and hospital  Department of anaesthesiology, new OT,1st floor, JLN hospital, Kalabagh
Ajmer
RAJASTHAN 
7891071516

drpksmbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethecal committee Jawarlal Nehru medical college, Ajmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  BMI less then thirty kilogram per meter square
ASA physical status first and second
Schedule for elective surgery under general anesthesia requiring endotracheal intubation 
 
ExclusionCriteria 
Details  Obvious anatomical abnormality
Recent head and neck surgery
Disability to open the mouth
Upper airway abnormality
Cervical spine injury
Neck mass
Temporo-mandibular joint ankylosis
Facial and tongue anomalies
History of obstructive sleep apnea
BMI more then and equal to thirty kilogram per meter square
ASA physical status third and above
Edentolous  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of acromio-axillo suprasternal notch index test for prediction of difficult visualization of larynx  Base line 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of acromio-axillo suprasternal notch index with other bedside test such as upper lip bite test, ratio of height to thyromental distance, thyromental height test for prediction of difficult visualization of larynx   Base line 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   18/04/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study will be a prospective, comparative, double blinded, observational study. Patients will be included, age more then 60 years, of either sex, BMI  < 30 kg/m2, ASA physical status I and II and schedule for elective surgery under general anaesthesia requiring endotracheal intubation. Aim is comparison of newer airway assessment tests include acromio-axillo suprasternal notch index (AASI), upper lip bite test (ULBT), ratio of height to thyromental distance (RHTMD), thyromental height test (TMHT) and for prediction of difficult visualization of larynx (DVL) in geriatric population.

Primary objective is to evaluate the efficacy of AASI (sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy) for prediction of DVL preoperative and secondary objective is to compare AASI with other bedside tests such as ULBT, RHTMD and TMHT for prediction of DVL and correlation of above assessment tools with modified Cormack - Lehane grading (MCLG) for glottic visualization.

All the patients will be subjected to detailed history, complete physical as well as systemic examination before surgery in preoperative checkup. Patient’s required parameters, routine and all relevant investigations will be checked. The purpose and protocol of the study will be explained to the patients and informed written consent will be obtained.

In the operating room  a standardized anesthesia technique will be followed to give anaesthesia to patient. Laryngoscopy will be performed and the laryngoscopic view will be graded using MCLG grading. All the parameter will be recorded and documented and analyzed using standard qualitative and quantitative test.

 
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