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CTRI Number  CTRI/2025/09/094791 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of ultrasonographic airway parameters in improving the quality, safety and efficacy of airway management. 
Scientific Title of Study   Role of ultrasonographic parameters in DARES criteria for improving the quality, safety and efficacy of airway management: A prospective study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Govt medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal thellakom. P.o, kottayam Kerala
thellakom. P.o, kottayam
Kottayam
KERALA
686630
India 
Phone  09447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Govt medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal thellakom. P.o, kottayam Kerala
thellakom. P.o, kottayam
Kottayam
KERALA
686630
India 
Phone  09447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sheeba franklin 
Designation  Additional professor, department of anesthesiology, Govt medical college, Kottayam  
Affiliation  Government Medical College Kottayam 
Address  Njondimackal thellakom. P.o, kottayam Kerala
thellakom. P.o, kottayam
Kottayam
KERALA
686630
India 
Phone  09447315132  
Fax    
Email  sheebabinu04@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Government medical college, kottayam 
Address  Department of Anesthesia, Government medical College, Kottayam. 
Type of Sponsor  Government 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 
Sheeba franklin  Government medical college,kottayam  Department of Anesthesiology, Preanesthetic clinic
Kottayam
KERALA 		 09447315132

sheebabinu04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION REVIEW BOARD   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  elective intubation planned for surgery of any disease. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients
of either sex, ASA I or II, scheduled for surgical procedures under general
anesthesia requiring intubation at Government Medical College, Kottayam during 2025-2026. 
 
ExclusionCriteria 
Details  The exclusion criteria for ultrasonographic study will be limited neck mobility secondary to cervical spine fractures or tumours, limited neck extension including arthritis, documented history of difficult intubation, pregnant women, post burns contracture of neck or perioral region. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be
1.Indication of surgery
2.Predictors (clinical and ultrasonographic) of difficult face mask ventilation or intubation
3.To determine the Total intubation time (in seconds)
4.To compare the visualization of airway using Modified Cormack-Lehane grading.
5.To assess the ease of intubation (score)
 		 Date of first enrolment : 01- 10- 2025.
Date of study completion : 01- 03- 2026. Date of IRB Approval : 27- 02- 2024
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of intubation attempts required
2.Any rescue devices used.
3.Any airway related complications
 		 Date of first enrolment : 01- 10- 2025.
Date of study completion : 01- 03- 2026.
Date of IRB Approval : 27- 02- 2024
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/10/2025 
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="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sheebabinu04@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 30-09-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Airway management involves preoperative evaluation. Ultrasonography is a very good method by predicting Cormack  lehane score and correlating with difficult laryngoscopy. Dares criteria involves Distance from skin to epiglottis, hyo mental distance, hyo mental distance ratio 1 , (ratio of hyo mental distance in ramped position to head in neutral position0. and hyo mental distance ratio 2 ( Hyo mental distance in hyperextended position to  neutral position)and  Tongue thickness . Cormack lehane score on direct laryngoscopy grade 3 and 4 is difficult laryngoscopy.HMDR1 less than 1.12 and HMDR2 less than 1.08, Tongue thickness more than 6cm and Distance from skin to epiglottis more than 2.5cm is the cutoff for difficult laryngoscopy. Area under the curve , sensitivity and specificity of the predictive model can be used for predicting difficult laryngoscopy  
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