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CTRI Number  CTRI/2025/06/088414 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   COMPARISON OF ULTRASONOGRAPHY, COMPUTED TOMOGRAPHY AND CLINICAL AIRWAY ASSESSMENT TESTS FOR PREDICTING DIFFICULT LARYNGOSCOPY IN PATIENTS UNDERGOING HEAD AND NECK SURGERY 
Scientific Title of Study   COMPARISON OF ULTRASONOGRAPHY, COMPUTED TOMOGRAPHY AND CLINICAL AIRWAY ASSESSMENT TESTS FOR PREDICTING DIFFICULT LARYNGOSCOPY IN PATIENTS UNDERGOING HEAD AND NECK SURGERY: A PROSPECTIVE RANDOMISED DOUBLE-BLIND COHORT 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  DR ROHIT RAMAN BANERJI 
Designation  DNB - REGISTRAR 
Affiliation  FORTIS ESCORTS HOSPITAL, JAIPUR  
Address  Room 4202, Multi Specialty OT Complex, Second Floor, Department of Anaesthesiology, Fortis Escorts Hospital Jaipir, J.L.N Marg, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur, Rajasthan, India 302017FORTIS ESCORTS HOSPITAL, JAIPUR Jaipur RAJASTHAN 302017 India

Jaipur
RAJASTHAN
302017
India 
Phone  9667788220  
Fax    
Email  banerjirohitraman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR JYOTSNA BHARGAVA 
Designation  ADDITIONAL DIRECTOR 
Affiliation  FORTIS ESCORTS HOSPITAL, JAIPUR  
Address  Room 4202, Multi Specialty OT Complex, Second Floor, Department of Anaesthesiology, Fortis Escorts Hospital Jaipir, J.L.N Marg, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur, Rajasthan, India 302017FORTIS ESCORTS HOSPITAL, JAIPUR

Jaipur
RAJASTHAN
302017
India 
Phone  9928077934  
Fax    
Email  joysam123@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR JYOTSNA BHARGAVA 
Designation  ADDITIONAL DIRECTOR 
Affiliation  FORTIS ESCORTS HOSPITAL, JAIPUR  
Address  Room 4202, Multi Specialty OT Complex, Second Floor, Department of Anaesthesiology, Fortis Escorts Hospital Jaipir, J.L.N Marg, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur, Rajasthan, India 302017

Jaipur
RAJASTHAN
302017
India 
Phone  9928077934  
Fax    
Email  joysam123@yahoo.co.in  
 
Source of Monetary or Material Support  
Multi Specialty OT Complex, Second Floor, Department of Anaesthesiology, Fortis Escorts Hospital Jaipir, J.L.N Marg, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur, Rajasthan, India 302017 
 
Primary Sponsor  
Name  DR JYOTSNA BHARGAVA 
Address  FORTIS ESCORTS HOSPITAL,JAIPUR  
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 
DR JYOTSNA BHARGAVA  FORTIS ESCORTS HOSPITAL  Pre Anaesthetic Checkup Room, Multi Specialty OT Complex, Second Floor, Department of Anaesthesiology, Fortis Escorts Hospital Jaipir, J.L.N Marg, Jawahar Lal Nehru Marg, Malviya Nagar, Jaipur, Rajasthan, India 302017
Jaipur
RAJASTHAN 		 9928077934

joysam123@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FORTIS ESCORTS HOSPITAL, JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Planned for elective Head and neck surgery 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinical Airway Assessment  Analysing the various airway parameters of patients uaing bedside clinical airway assessment methods like Mallampati grade, neck extension 
Comparator Agent  CT SCAN   Analysing the various airway parameters of patients using the CT scan [already done by surgery team whileplanning for surgery]. 
Intervention  Nil  Nil 
Comparator Agent  USG - AIRWAY  Analysing the various airway parameters of patients using USG. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients (18 years or older)
Scheduled for elective head and neck surgery Patients requiring general anesthesia with endotracheal intubation
ASA I, II or III 
 
ExclusionCriteria 
Details  Patient refusal - Emergency or urgent cases Patients with contraindications to CT scan (e.g., Parturient, etc.)
Patients with an already known history of difficult airway
Patients with altered mental sensorium, dementia etc
Patients unable to follow commands. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Clinical Airway Assessment Tests, Ultrasound and CT scan in predicting difficult laryngoscopy in patients undergoing head and neck surgeries on the basis of difficulty encountered during laryngoscopy.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the accuracy, sensitivity, & specificity of Clinical Airway Assessment Tests in predicting difficult laryngoscopy  At baseline 
To determine the accuracy, sensitivity, & specificity of Ultrasound in predicting
difficult laryngoscopy. 		 At baseline 
To determine the accuracy, sensitivity, & specificity of CT scan in predicting difficult laryngoscopy.  At baseline 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   16/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [banerjirohitraman@gmail.com].

  6. For how long will this data be available start date provided 01-06-2023 and end date provided 30-06-2029?
    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 is of prime importance to an anaesthesiologist. Encountering an unanticipated difficult airway (DA) is not an uncommon scenario. It poses potentially life-threatening problems.

Anaesthesiologists still rely on preoperative assessment of numerous anatomic and clinical features for identification of DA. However, none of the commonly used clinical predictors has sensitivity or specificity of 100%. Utilisation of radiology (viz., Ultrasonography and Computed Tomography) for ‘visualisation’ of actual bony and soft tissue structures to assist in prediction of DA could thus be of immense help to the anaesthesiologist.

They also find use in cases of trauma for diagnosis of laryngeal fractures, epiglottic avulsion or dislocation, soft tissue disruptions, mucosal oedema, and foreign body and formulating plan for airway management.

Therefore, our pilot study aims to compare the effectiveness of clinical airway assessment tests, ultrasound and CT scan in predicting difficult laryngoscopy in patients undergoing head and neck surgery.

 
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