FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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
 
Close