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CTRI Number  CTRI/2025/10/095690 [Registered on: 07/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A Study on Using Shoulder and Neck Measurements to Predict Breathing Tube Placement Difficulty in Patients undergoing surgery. 
Scientific Title of Study   A prospective observational study of the performance of the acromioaxillosuprasternal notch index in predicting difficult visualization of the larynx 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sathish kumar M 
Designation  MD Anesthesiology Post graduate 
Affiliation  Chettinad hospital and research institute 
Address  Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103

Chennai
TAMIL NADU
603103
India 
Phone  9840380716  
Fax    
Email  sathishkumar2march95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Ashok kulasekar 
Designation  Head of the department, Anesthesiology.  
Affiliation  Chettinad hospital and research institute 
Address  Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103

Chennai
TAMIL NADU
603103
India 
Phone  9840498420  
Fax    
Email  ashokk_dr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sathish kumar M 
Designation  MD Anesthesiology Post graduate 
Affiliation  Chettinad hospital and research institute 
Address  Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103

Chennai
TAMIL NADU
603103
India 
Phone  9840380716  
Fax    
Email  sathishkumar2march95@gmail.com  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, india, pincode-603103. 
 
Primary Sponsor  
Name  Sathish kumar M 
Address  Chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103 
Type of Sponsor  Other [This study is self-sponsored, with myself as the primary sponsor.] 
 
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 Sathish kumar M  Chettinad hospital and research institute  B block, 2nd floor, ICU-3, department of anesthesiology, chettinad hospital and research institute, rajiv gandhi salai (omr), kelambakkam, tamilnadu, pincode-603103
Chennai
TAMIL NADU 
9840380716

sathishkumar2march95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee for student research (CARE IHEC-I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z018||Encounter for other specified special examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18-60 years
ASA grade -1,2
Patients undergoing surgery under general anaesthesia. 
 
ExclusionCriteria 
Details  Patient who denies consent
Patient with prominent features of the difficult airway with facial abnormalities
Morbid obesity BMI more than 35kg/sq.m
Restricted mouth opening, edentulous
Cervical spine anomalies
Uncooperative and pregnant patients
Patients with anatomical deformity of head, neck and thorax 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the incidence of difficult laryngoscopy(Cormack-lehane grade III-IV) measured at the time of laryngoscopy immediately after induction of anesthesia  The outcome of difficult visualization of the larynx will be assessed at the time of laryngoscopy during induction of anesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   01/11/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Inclusion criteria  Age: 18-60 years , ASA grade -1,2 , Patients undergoing surgery under general anesthesia. Exclusion criteria Patients who denies consent, Patients with prominent features of the difficult airway with facial abnormalities, Morbid obesity body mass index BMI more than 35 kg/sq.m , Restricted mouth opening, edentulous, Cervical spine anomalies, Uncooperative and pregnant patients. Patients with anatomical deformity of head, neck, thorax. After obtaining
approval from Ethics committee Informed and written consent will be obtained from all patients PREOPERATIVE ASSESSMENT  including Detailed history and physical examination, baseline data like heart rate, blood pressure and basic investigations will be collected. Modified mallampatti grading (1,2,3,4), Mouth opening (more or less than 3 finger breath) ,Thyromental distance (more or less than 6.5 cm) , sternomental distance (more or less than 12.5cm) , Hyomental distance (more or less than 4.5 cm), inter incisor distance (more than or less than 4cm ), body mass index  will be noted .An Intravenous  access with 18G IV cannula will be secured for all patients. Premedication such as Tablet Ranitidine 150mg and Tablet Alprazolam 0.5mg given a night before surgery and 6 am on the day of surgery ACROMIO AXILLO SUPRASTERNAL NOTCH INDEX was measured with the patients lying in supine position and their upper limbs resting by the sides of the body Using a ruler  a vertical line was drawn from top of the acromion process to the superior border of the axilla at the pectoralis muscle –line A The second line was drawn perpendicular to line A from the suprasternal notch – line B. The portion of line A that lay above the point at which line B intersected line A was termed as -line C .AASI was calculated by dividing the length of line C by that of line A ( AASI =C/A) . An AASI value of 0.49 or less has been identified as a predictor of difficult laryngoscopy (intubation)
 
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