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CTRI Number  CTRI/2022/07/044138 [Registered on: 19/07/2022] Trial Registered Prospectively
Last Modified On: 08/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   ULTRASOUND EVALUATION OF ANTERIOR NECK SOFT TISSUE THICKNESS TO PREDICT DIFFICULT LARYNGOSCOPY IN OVERWEIGHT ADULT PATIENTS POSTED FOR SURGERY UNDER GENERAL ENDOTRACHEAL ANAESTHESIA - AN OBSERVATIONAL STUDY. 
Scientific Title of Study   ULTRASOUND EVALUATION OF ANTERIOR NECK SOFT TISSUE THICKNESS TO PREDICT DIFFICULT LARYNGOSCOPY IN OVERWEIGHT ADULT PATIENTS POSTED FOR SURGERY UNDER GENERAL ENDOTRACHEAL ANAESTHESIA - AN OBSERVATIONAL STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AJNAS AP 
Designation  JUNIOR RESIDENT 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.

Mysore
KARNATAKA
570004
India 
Phone  9946165525  
Fax    
Email  ajnasanappara@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF DR ARCHANA K N 
Designation  PROFESSOR 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.

Mysore
KARNATAKA
570004
India 
Phone    
Fax    
Email  archanamrnm@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  PROF DR ARCHANA K N 
Designation  PROFESSOR 
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.

Mysore
KARNATAKA
570004
India 
Phone    
Fax    
Email  archanamrnm@yahoo.co.in  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND JSS HOSPITAL , MYSORE 
 
Primary Sponsor  
Name  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004. 
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 AJNAS AP  JSS MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.
Mysore
KARNATAKA 
9946165525

ajnasanappara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. 18 to 65 years old patients of either sex
2. BMI more than 25 kg/ m²
3. ASA physical status grade I to III 
 
ExclusionCriteria 
Details  1.Patients with facial fractures
2.Maxillofacial abnormalities
3.Cervical spinal fracture
4. Arthritis,
5.Pregnancy
6. Emergency cases 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
-Ultrasonographic measurement of anterior neck soft tissue thickness at 3 levels
-Distance from skin to hyoid bone (DSHB)
-Distance from skin to thyrohyoid membrane (DSTM)
-Distance from.skin to anterior commissure of vocal cord (DSAC)
and to compare and correlate the findings with Cooks modification of Cormack Lehane score in predicting difficult laryngoscopy 
-Ultrasonographic measurement of anterior neck soft tissue thickness at 3 levels 30 minutes before proposed surgery
-Distance from skin to hyoid bone (DSHB)
-Distance from skin to thyrohyoid membrane (DSTM)
-Distance from.skin to anterior commissure of vocal cord (DSAC)
and to compare and correlate the findings with Cooks modification of Cormack Lehane score in predicting difficult laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and correlate the ultrasonographic measurement of anterior neck soft tissue thickness with conventional assesment methods (Modified mallampatti score, thyromental distance, interincisor gap, sternomental distance and neck movements) in predicting difficult laryngoscopy  5mins 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/07/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Patients in the age group of 18 to 65 of either sex with BMI above 25 kg / m² who are undergoing elective surgery under general endotracheal anaesthesia will be enrolled for the study with written informed consent. A day before the surgery a thorough preanaesthetic evaluation and assessment of the airway is done using conventional (Modified mallampatti score, thyromental distance,  interincisor gap, neck movements and sternomental distance) assesment methods. Then on the day of surgery in the preoperative room ultrasonographic measurement of anterior neck at 3levels: Distance from skin to hyoid bone(DSHB), Distance from skin to anterior commisure of vocal cord (DSAC) and Distance from skin to thyrohyoid membrane (DSTM) at midline will be performed with the patient lying in supine with head and neck in neutral position using Logiq p6 pro ultrasound system manufactured by GE health care

On the day of surgery  after connecting the monitors and securing intravenous lines patient is  preoxygenated for 3 minutes with 100 % oxygen and  premedicated with Inj. midazolam 0.1mg/kg  iv and Inj.Fentanyl 1 microgram/kg iv. For intravenous induction Inj. propofol 2 mg/kg will be used. After ensuring adequate ventilation, Inj succinylcholine 1.5 mg/kg will be given to achieve adequate muscle relaxation. All laryngoscopies will be done by experienced anaesthesiologists by macintosh laryngoscope using conventional methods and cooks modification of Cormack Lehane Grading will be assessed. Time takennumber of attempts and any manipulations necessary to intubate will be noted.

Modified Mallampatti classification (MMC).

• Class I is visualization of soft palate,uvula, fauces, and pillars. 
• Class II is visualization of softpalate, uvula and fauces. 
• Class III is visualization of softpalate and base of uvula. 
• Class IV is only hard palate being visible

 
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