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CTRI Number  CTRI/2025/07/091220 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Use of ultrasound to assess the airway for easier intubation in patients with cervical spine problems during general anesthesia  
Scientific Title of Study   Evaluation of ultrasound-guided airway parameters and their association with ease of intubation in patients with cervical spine pathologies undergoing intubation under general anesthesia: A prospective observational 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  Saumya Adhikari 
Designation  Post Graduate Student 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh 
Address  Room No. 016133 Department of Anaesthesiology ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh ,Shivaji Nagar, Veerbhadra Road, Rishikesh, Uttarakhand 249203 , India

Dehradun
UTTARANCHAL
249203
India 
Phone  919997395780  
Fax    
Email  asaumya145@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Agrawal 
Designation  Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh 
Address  Room No. 016133 Department of Anaesthesiology ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh ,Shivaji Nagar, Veerbhadra Road, Rishikesh, Uttarakhand 249203 , India

Dehradun
UTTARANCHAL
249203
India 
Phone  919761712630  
Fax    
Email  sanjay.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Agrawal 
Designation  Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh 
Address  Room No. 016133 Department of Anaesthesiology ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh ,Shivaji Nagar, Veerbhadra Road, Rishikesh, Uttarakhand 249203 , India

Dehradun
UTTARANCHAL
249203
India 
Phone  919761712630  
Fax    
Email  sanjay.anaes@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS) RISHIKESH 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh ,Shivaji Nagar, Veerbhadra Road, Rishikesh, Uttarakhand 249203, India 
Type of Sponsor  Research institution and hospital 
 
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 
DrSaumya Adhikari  ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh  Room no. 016133 Department of Anaesthesiology AIIMS RISHIKESH VIRBHADRA ROAD RISHIKESH, UTTARAKHAND
Dehradun
UTTARANCHAL 		 9997395780

asaumya145@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS) Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I, II, III, Diagnosed with cervical spine pathology (Rheumatoid arthritis, Cervical spondylosis, Ankylosing spondylitis, Prolapsed intervertebral disc, Craniovertebral junction anomalies, Infective pathology), Scheduled for elective surgery requiring airway management
 
 
ExclusionCriteria 
Details  ASA grade IV, V,Patients with head and neck malignancies affecting airway anatomy and mouth opening,Patients with major neurological sequlae (weakness, paresis, bladder & bowel disturbances),Patients with prior tracheostomy or airway surgery, Patients with anticipated difficult intubation on physical airway assessment, Obesity with BMI greater than 30kg/m2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine incidence of difficult laryngoscopy and difficult intubation in patients predicted with difficult airway via ultrasonography
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the predictive ability of clinical airway predictors
To compare the efficacy of clinical & sonographic airway parameters for predicting difficult airway 		 Baseline 
 
Target Sample Size   Total Sample Size="107"
Sample Size from India="107" 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjay.anaes@aiimsrishikesh.edu.in].

  6. For how long will this data be available start date provided 10-01-2025 and end date provided 10-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

All the patients satisfying inclusion criteria will be evaluated at least one day prior to surgery

All of the patients will be kept nil per oral for solids for 8hrs and clear fluids upto 2 hrs prior to surgery. No sedative premedication will be administered in any of the patient.

Demographic and preoperative data such as age , sex , weight , BMI , Diagnosis of the patient, neurological status will be recorded along with ASA grade

In the preoperative ward the USG guided airway parameters will be assessed utilizing curvilinear and linear probe. Patients will be positioned in a supine position with head in neutral position, the mouth closed and the tongue on the floor of the mouth without any movement. Different parameters will be noted. Neck extension will not be done in any patient for USG guided airway assessment.

After shifting the patient to operation theatre , patient will be placed in supine position and ASA standard monitors (noninvasive blood pressure (NIBP) , Electrocardiography (ECG) , Pulse oximeter (Spo2) will be attached.

Peripheral IV cannulation will be done and infusion of Ringer Lactate will be started.

Anaesthesia in all the cases will be induced using Injection(Inj) Fentanyl 2mcg/kg, Inj Propofol 2 mg/kg and Vecuronium 0.1 mg/kg.Check ventilation will be done.Manual inline stabilization will be applied in all the cases.

Laryngocopy will be conducted by an experienced anesthesiologist with >3years of experience maintaining manual inline stabilization utilizing standard laryngoscope and Cormack Lehane grading will be recorded. Alternately Video laryngoscope maybe used and POGO score recorded.

Maintenance of anaesthesia will be done using 50 % oxygen in air , Sevoflurane (0.8 - 1.0 MAC) with intermittent boluses of inj.Vecuronium 0.02 mg/kg.

Central venous catheter of 7 FG will be placed in right internal jugular vein or subclavian vein and right radial artery will be cannulated for invasive blood pressure monitoring as per need of surgery.

 

 
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