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CTRI Number  CTRI/2024/08/072941 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 19/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to find out change in localisation of a membrane by present in front of neck, that is needed through which an instrument can be inserted to provide oxygen in patients in case of breathlessness using sonography in different positions of neck 
Scientific Title of Study   Effect of change in head and neck position on ultrasonographic localisation of cricothyroid membrane : An 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 Prerana Nirav Shah 
Designation  Professor 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital  
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9869117027  
Fax    
Email  pps@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amruta Pradeep More 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9552991088  
Fax    
Email  amrutamore1298@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amruta Pradeep More 
Designation  Resident 
Affiliation  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012


MAHARASHTRA
400012
India 
Phone  9552991088  
Fax    
Email  amrutamore1298@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India  
 
Primary Sponsor  
Name  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital 
Address  Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA Mumbai MAHARASHTRA 
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 Amruta Pradeep More  Seth Gordhandas Sunderdas Medical College King Edward Memorial Hospital   Department of Anaesthesiology 1st Floor Old Building GSMC KEMH Parel Mumbai Maharashtra 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9552991088

amrutamore1298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe (IEC)-III) Relating to Biomedical and Health Research  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age between 18– 65 years
Both genders
Patients posted for elective surgeries under General anaesthesia
 
 
ExclusionCriteria 
Details  Patient who refuse to participate in the study.
Pregnant patients
Patients in whom extension of neck is not possible/ restricted.
( eg .cervical spondylitis, degenerative disc disease)
Patients having history of trauma to neck and jaw.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to assess change in location of surface marking of center of the Cricothyroid membrane with head and neck in neutral and in extension position   Preoperative before induction 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective is to determine change in height of the Cricothyroid membrane with head and neck in neutral and in extension position.  Preoperative before induction 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

As securing airway through front of neck is essential measure in cannot intubate cannot ventilate situation and thus cricothyroid membrane(CTM) localisation is crucial step.The preferred position for standard airway management and for surgical Cricothyrotomy are different.

So skin marking for cricothyroid membrane in head and neck in neutral position might not be same when head and neck is in extension position. And also during extension of head and neck the height of cricothyroid membrane might increase. So localisation of cricothyroid membrane as precautionary measure is important.

The study aims to assess the effect of change in head and neck position on ultrasonographic localisation of cricothyroid membrane.

The primary objective of the study is to investigate whether a skin mark placed directly over the center of the cricothyroid membrane (CTM), while the head and neck are in a neutral position, shifted beyond the CTM boundaries during head and neck extension. The secondary objective is  to ascertain if the distance between the upper and lower boundaries (height) of the CTM altered when the head and neck transitioned from a neutral to an extended position. Every patient will lie supine on an operating theatre trolley, with their head rested on a pillow to attain a neutral position of the head and neck.The upper and lower borders of the CTM using a linear ultrasound probe will be identified and marked.The height of membrane will be measured and centre of Cricothyroid membrane will be marked. After that  patient will be asked to extend head and neck and again same measurements will be recorded.

 
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