| 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
|
|
|
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
|
|
|
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. |