| CTRI Number |
CTRI/2023/10/058533 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
USING ULTRASOUND TO MEASURE ANTERIOR NECK TISSUE FOR PREDICTING DIFFICULT LARYNGOSCOPY IN ICU PATIENT. |
|
Scientific Title of Study
|
ULTRASOUND GUIDED MEASUREMENT OF ANTERIOR NECK TISSUE FOR THE PREDICTION OF DIFFICULT LARYNGOSCOPY IN ICU 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 |
Dr Vivilia Arockia Jenitta A |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
2ND FLOOR,
MSRIT post Bangalore
KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9986542071 |
| Fax |
|
| Email |
jenitaarockia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Roopa Rani k |
| Designation |
professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
2ND FLOOR
MSRIT post Bangalore
KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9686709000 |
| Fax |
|
| Email |
drrooparani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopa Rani K |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
2ND FLOOR
MSRIT post Bangalore
KARNATAKA
Bangalore KARNATAKA 560054 India |
| Phone |
9686709000 |
| Fax |
|
| Email |
drrooparani@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College Bangalore MSRIT Post Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
MSRIT post New BEL Road Bangalore 560054 |
| Type of Sponsor |
Private 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 Vivilia Arockia Jenitta A |
MS Ramaiah College Hospital |
Department of Anaesthesiology
Second floor MS Ramaiah Medical College Hospital New BEL Road Bangalore Karnataka Bangalore KARNATAKA |
9986542071
jenitaarockia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted in ICU requiring Elective Intubation and Ventilatory support. |
|
| ExclusionCriteria |
| Details |
Patient with facial trauma, neck swelling and cervical spine injury.
pregnant women. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict difficult laryngoscopy by ultrasound guided valuation of anterior neck soft tissue thickness. |
To predict difficult laryngoscopy before intubation by measurement of neck tissue by using ultrasound while performing the procedure at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the Sensitivity & Specificity of distance from skin to hyoid bone DSHB Distance from skin to anterior commissure of vocal cords DSAC & skin to thyrohyoid membrane DSEM in prediction of difficult laryngoscopy |
Overall to asses the specificity & sensitivity of parameter in prediction of difficult laryngoscopy after the procedure at the baseline |
|
|
Target Sample Size
|
Total Sample Size="91" Sample Size from India="91"
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)
|
21/10/2023 |
| 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="2" Months="0" 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
|
Predicting difficult intubation through airway evaluation is critical in Anaesthesia practise there are several clinical predictors for difficult airway assessment even for an experienced anaesthesiologist an unexpected difficult airway is a terrifying nightmare because it can result in life threatening Anaesthesia related morbidity and mortality
Despite the use of a variety of screening tests such as the Mallampati score inter incisor gap and thyromental distance the rate of difficult laryngoscopy and intubation remains 1.5 to 13 percent this highlights the uncertainty of traditional tests and the need for more dependable test parameters ultrasound has evolved as a simple non invasive portable and quick airway assessment technique it is well known for its regional block central venous catheterization and detecting pneumothorax in the operating room and intensive care units several studies have recently described its use in visualising airway structures
Researchers have taken advantage of this advancement to obtain ultrasound guided measurement of parameter such as anterior commissure vocal cords and so on to the level of the skin the thyrohyoid membrane and hyoid bone are attached they attempted how these parameters can aid in the detection of a difficult airway
The Anaesthesiologist primary responsibility is to ensure that the patient receives adequate ventilation. the airway is the most important component in this difficulties with optimal airway management can have serious consequences and failure can result in death we assessed the feasibility of sonography as an imaging tool for identifying important airway anatomical structures on the anterior aspect of the neck and correlated ultrasound guided measurement of airway parameter with Cormack Lehane classification of direct laryngoscopy for prediction of difficult airways in this study we will be predicting difficult laryngoscopy by ultrasound guided valuation of anterior neck soft tissue thickness |