| CTRI Number |
CTRI/2023/09/057406 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasonographic assessment of anterior neck for predicting difficult laryngoscopy in adult patients. |
|
Scientific Title of Study
|
Ultrasonographic assessment of anterior neck for predicting difficult laryngoscopy in adult patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department Of Aaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital
South DELHI 110029 India |
| Phone |
9910963099 |
| Fax |
|
| Email |
deepikarana855@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kapil Gupta |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department Of Anaesthesia
Vardhman Mahavir Medical College And Safdarjung Hospital
South DELHI 110029 India |
| Phone |
9811859019 |
| Fax |
|
| Email |
kapgup11@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Kapil Gupta |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department Of Anaesthesia
Vardhman Mahavir Medical College And Safdarjung Hospital
South DELHI 110029 India |
| Phone |
9811859019 |
| Fax |
|
| Email |
kapgup11@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi 110029 |
| 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 DEEPIKA |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Department Of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi 110029 South DELHI |
9910963099
deepikarana855@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia requiring Endo-Tracheal Intubation. |
|
| ExclusionCriteria |
| Details |
1.Morbid obesity( BMI>40kg/meter square).
2.Neck deformity, Restricted neck movements, neck mass, neck contracture.
3.Anticipated difficult airway.
4.Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of ultrasonographic assessment of anterior neck structure at the level of epiglottis [Distance from skin to epiglottis (DSE)] in predicting difficult laryngoscopy (Cormack-Lehane grade 3 and 4) in adult patients undergoing elective surgery. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare ultrasonographic measurements of combination of airway parameters (skin to epiglottis distance, skin to hyoid bone distance & skin to vocal cord distance) with clinical measurements in predicting difficult laryngoscopy. |
At the time of induction of anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/10/2023 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Airway examination is of prime importance for an anesthesiologist. A patient needing airway management requires assessment for difficult airway. A difficult airway may prohibit mask ventilation or can also lead to repeated failed intubation, this can lead to decrease blood supply to essential organs of body. Multiple clinical parameters are used to predict difficult airway but incidence of difficult laryngoscopy still ranges between 1.5%-13% probably due to high inter observer differences. Ultrasound is evolving as a useful tool in airway assessment now a days. Ultrasound has several
advantages for imaging of the airway - it is safe, quick, repeatable, portable, widely available. Patient will be asked to lie supine on a firm surface for ultrasound
assessment of anterior neck tissue thickness at the level of hyoid bone, epiglottis and vocal
cords using linear probe. Sonographically epiglottis appear as curvilinear, hypoechoic structure with an echogenic pre epiglottic space. Hyoid bone appears as curved echogenic structure with a bright posterior air mucosal interface and
hyperechoic pre-epiglottic space. Thyroid cartilage provides the window to view the vocal cords. Vocal cords forms an isosceles
triangle with a central tracheal shadow. However, not not much research have been done for predicting difficult laryngoscopy using ultrasound. Thus, we are planning to do this study to predict difficult laryngoscopy by using ultrasound and measuring it with clinical parameters. |