FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/051792 [Registered on: 19/04/2023] Trial Registered Prospectively
Last Modified On: 19/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   ACROMIO-AXILLO-SUPRASTERNAL NOTCH INDEX AS SCREENING TEST TO PREDICT DIFFICULT LARYNGOSCOPY 
Scientific Title of Study   An observational study to determine Acromio-Axillo-Suprasternal notch index as screening test to predict difficult laryngoscopy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEETU RENY 
Designation  Postgraduate 
Affiliation  KASTURBA MEDICAL COLLEGE 
Address  Department Of Anaesthesiology Kasturba Medical College Manipal Academy Of Higher Education Manipal Karnataka
Manipal Academy Of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India 
Phone  8606524256  
Fax    
Email  neetureny@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MEGHA T 
Designation  ASSISTANT PROFESSOR 
Affiliation  KASTURBA MEDICAL COLLEGE 
Address  Department Of Anaesthesiology Kasturba Medical College Manipal Academy Of Higher Education Manipal Karnataka
Manipal Academy Of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9164694619  
Fax    
Email  megha.maggidec@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MEGHA T 
Designation  ASSISTANT PROFESSOR 
Affiliation  KASTURBA MEDICAL COLLEGE 
Address  Department Of Anaesthesiology Kasturba Medical College Manipal Academy Of Higher Education Manipal Karnataka
Manipal Academy Of Higher Education Manipal Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9164694619  
Fax    
Email  megha.maggidec@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Academy Of Higher Education Manipal Karnataka 
 
Primary Sponsor  
Name  NEETU RENY 
Address  Kasturba Medical College Manipal Academy Of Higher Education Manipal Karnataka 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
kasturba medical college  MANIPAL ACADEMY OF HIGHER EDUCATION MANIPAL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neetu Reny  Kasturba Medical College  OT Complex Kasturba Medical college Manipal Academy of Higher Education manipal
Udupi
KARNATAKA 
8606524256

neetureny@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  undergoing elective under general anaesthesia belonging to American Society of Anaesthesiologists Physical Status I or II will be included in the study. 
 
ExclusionCriteria 
Details  1.Anatomical abnormalities(limitation of TMJ and Atlanto-axial joint, oral tumors, maxillofacial tumors)
2.Recent Head and Neck surgery
3.Pregnant
4.Edentulous
5.BMI more than 35 Kg/m2
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine sensitivity and specificity of acromio-axillo-suprasternal notch index as screening test to predict difficult laryngoscopy  4 mins after administering Muscle Relaxant 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the predictive values of seven anatomical indices
Modified Mallampatti
Sternomental distance
Thyromental distance
Neck circumference
Ratio of height to thyromental distance
Upper lip bite test
Acromio-axillo-suprasternal notch index
 
4 mins after administering Muscle relaxant 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 3 
Date of First Enrollment (India)   25/04/2023 
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="2"
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  

•        Each patient will undergo physical examination before surgery & airway assessment tests – Acromio-axillo suprasternal notch index (AASI),  Modified Mallampati Test (MMT), Ratio Of Height to Thyromental Distance (RHTMD), Sternomental distance, Thyromental distance, Neck circumference, Upper lip bite test  will be assessed by the post graduate independent researcher who is not involved in subsequent study .

•        Patient is shifted to OT after confirming  NPO  and taking consent. ASA standard monitors attached.  pre-oxygenation is done  for 3 min with 100% oxygen  with all patients receiving analgesic Inj. Fentanyl 2mcg/kg.

•        Induction will be done with Inj. Propofol 2 mg/kg as starting dose and then subsequently titrated to loss of eye lash reflex.

•        After confirming successful bag and mask ventilation, direct laryngoscopy and tracheal intubation will be  facilitated with depolarising muscle relaxant.

•        With the head on a standard pillow of height 7cm and in the sniffing position, direct laryngoscopy was performed with Macintosh laryngoscope blade 3 by an anaesthesiologist with more than 2 years of experience. The laryngeal view was graded according to the Cormack and Lehane grading system .  PG who had  assessed the parameter preoperatively will note down the findings.

•        Total number of intubation attempts, number of involved anaesthesiologists, alternate techniques used, requirement of additional lifting force, laryngeal pressure applied, vocal cord mobility is noted down .

 
Close