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CTRI Number  CTRI/2024/09/073532 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   the use of ultrasound imaging to examine the airway of a patient posted for a neurosurgical procedure prior to general anesthesia and to correlate with difficult intubation  
Scientific Title of Study   Ultrasound guided upper airway assessment in predicting difficult airway in the Neurosurgical population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  jyothsna jayatheerthan 
Designation  junior resident 
Affiliation  kasturba medical college and kasturba hospital 
Address  Department of Anaesthesiology Kasturba Medical college and Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9789846691  
Fax    
Email  jyothsna.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  ravitej bhat 
Designation  assistant professor  
Affiliation  kasturba medical college and kasturba hospital 
Address  Department of Anaesthesiology Kasturba Medical college and Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449990778  
Fax    
Email  ravitej30@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ravitej bhat 
Designation  assistant professor  
Affiliation  kasturba medical college and kasturba hospital 
Address  Department of Anaesthesiology Kasturba Medical college and Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449990778  
Fax    
Email  ravitej30@gmail.com  
 
Source of Monetary or Material Support  
kasturba medical college and kasturba hospital manipal karnataka, india 576104 
 
Primary Sponsor  
Name  jyothsna jayatheerthan 
Address  Department of Anaesthesiology Kasturba Medical college and Kasturba Hospital Manipal 
Type of Sponsor  Other [self] 
 
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 
jyothsna jayatheerthan  kasturba medical college and kasturba hospital  Department of Anaesthesiology Kasturba Medical college and Kasturba Hospital Manipal
Udupi
KARNATAKA 
09789846691

jyothsna.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba hospital institutional ethics committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and ASA 2 patients undergoing general anaesthesia undergoing elective neurosurgical population 
 
ExclusionCriteria 
Details  Known c-spine injury/pathology
History of cervical surgeries
Airway pathology (oral/pharyngeal/laryngotracheal mass lesions) detected
clinically or radiologically
Congenital disorders impacting spine and causing difficult airway

Parturients
Uncooperative patients
Unconscious patients
Any external disease of the face and neck that would preclude the use of
ultrasound probe placement 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
ultrasound upper airway parameters are measured in the preoperative holding area after consent on patients undergoing elective neurosurgical procedures  ultrasound upper airway parameters are measured in the preoperative holding area 30 minutes prior to shifting the patient inside the operation theatre after consent on patients undergoing elective neurosurgical procedures 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of ultrasound airway parameters with cormacke lehane grading of intubation  post intubation
ultrasound upper airway parameters are compared to cormacke lehane grading of intubation to establish difficulty
 
 
Target Sample Size   Total Sample Size="331"
Sample Size from India="331" 
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)   10/09/2024 
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="1"
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  
In the preoperative holding area, the primary investigator that is the
anaesthesiology post graduate will examine the upper airway by transcutaneous
Ultrasound and predict difficulty in laryngoscopy and intubation based on the
following parameters
1.Tongue thickness at the level of hyoid bone, Anterior neck soft tissue thickness
at the level of the hyoid bone measured from the skin on the short axis.
2. Tongue thickness at the level of thyrohyoid membrane
Anterior neck soft tissue thickness at the level of thyrohyoid membrane
3. Transverse tracheal air shadow diameter in the subglottic area of the front of
the neck
4. Soft tissue depth from the skin to the anterior part of the trachea, determined
at three levels: 1) vocal cords
2) thyroid isthmus
3) suprasternal notch

5. The distance from the epiglottis to the midpoint of the distance between the
vocal folds (E-VC) .
6. The depth of the pre-epiglottic space.
7. Depth of skin to epiglottis
8.Submandibular ultrasound
Hyomental distance measured in neutral
Hyomental distance measured in hyperextended position of the neck And their
ratio .
9.Tongue volume
10.The shortest distance from the skin to the anterior commissure.
11.Tongue thickness, Thyromental distance and their ratio.

The secondary investigator that is the anaesthesiology consultant who will be
blinded to the ultrasound measurements and its interpretation will intubate the
patient under general anaesthesia and establish the Cormack- Lehane grading.
Preoperatively he would have access to non ultrasound predictors of difficult
airway.
Data from ultrasound parameters and Cormack- Lehane ( CL) grading will be
correlated to check for accuracy in identifying difficult airway by ultrasound
predictors of difficult airway.
 
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