FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093477 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparison of Two Test(procedure) to Predict difficulty with intubation 
Scientific Title of Study   Comparison of acromio-axillo-suprasternal notch index with upper lip bite test to predict difficult intubation: 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  D R BINAY TEJA REDDY 
Designation  Resident Doctor  
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre  
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  09182420631  
Fax    
Email  binayteja15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Jigisha Mehta 
Designation  Associate Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre  
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  8866718168  
Fax    
Email  jbmehta.28@gmail.com  
 
Details of Contact Person
Public Query  
Name  D R BINAY TEJA REDDY 
Designation  Resident Doctor  
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre  
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  09182420631  
Fax    
Email  binayteja15@gmail.com  
 
Source of Monetary or Material Support  
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, pipariya, vadodara, gujarat, 391760  
 
Primary Sponsor  
Name  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre  
Address  Wagodia, pipariya, Vadodara, Gujarat, 391760 
Type of Sponsor  Private 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 
D R BINAY TEJA REDDY  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre   Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT 		 09182420631

binayteja15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committe   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  acromio-axillo-suprasternal notch index  it is the bedside test used to predict difficult intubation by measuring acromio axillo suprasternal notch index  
Comparator Agent  upper lip bite test  it is a bedside airway assessment that predicts difficult intubation by evaluating a patients ability to bite their upper lip with the lower incisors 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgeries that require general anesthesia and endotracheal intubation.
Both male and female patients.
Patients with a normal BMI (18.5 to 30) and no significant airway anomalies.
Written informed consent from the patient or legal guardian. 
 
ExclusionCriteria 
Details  patients with history of difficult intubation, with significant neck or spine tumours,
patients with BMI more than 35
pediatric and geriatric patients, pregnant woman
patitents who dont give consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
after the study observed values of AASI and upper lip bite test are compared to Cormack Lehane grades. An assessment is made regarding which screening test provides best results for predicting difficult visualization of larynx during laryngoscopy.  immediately after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
to asses which test among the two is better to assess the patients who will have difficulty during intubation   immediatey after intubation 
 
Target Sample Size   Total Sample Size="166"
Sample Size from India="166" 
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   Phase 4 
Date of First Enrollment (India)   05/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/09/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  binayteja15@gmail.com

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This prospective observational study aims to compare two simple bedside tests the Acromio-Axillo-Suprasternal Notch Index (AASNI) and the Upper Lip Bite Test (ULBT) to predict difficult intubation in patients undergoing anesthesia. By evaluating and correlating these tests with actual intubation outcomes, the study seeks to determine which test is more accurate and reliable for anticipating airway management challenges, ultimately helping improve patient safety during anesthesia.

 
Close