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CTRI Number  CTRI/2024/12/078532 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 21/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of Wilson’s score and Intubation prediction score for predicting difficulty in endotracheal intubation 
Scientific Title of Study   A prospective study to compare intubation prediction score versus Wilsons score for the prediction of difficult endotracheal intubation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apoorva Tarafdar 
Designation  Resident Doctor 
Affiliation  Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre 
Address  2nd floor, General OT complex, Anaesthesia Department, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8884850660  
Fax    
Email  apoorvatarafdar8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sara Mary Thomas 
Designation  Professor 
Affiliation  Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre 
Address  2nd floor, General OT complex, Anaesthesia Department, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sara Mary Thomas 
Designation  Professor 
Affiliation  Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre 
Address  2nd floor, General OT complex, Anaesthesia Department, Dhiraj Hospital, Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Waghodia, Piparia, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Source of Monetary or Material Support  
Sumandeep Vidyapeeth Deemed to be university, Piparia, Taluka Waghodiya, Vadodara, 391760, Gujarat, India 
 
Primary Sponsor  
Name  Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Sumandeep Vidyapeeth, Piparia, Taluka Waghodiya, Vadodara, 391760, Gujarat, India 
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 
Apoorva Tarafdar  Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department , General Ot Complex, 2nd Floor, Sumandeep Vidyapeeth Deemed to be University, Wagodhia , Pipariya, Vadodara. Pincode 391760
Vadodara
GUJARAT 		 8884850660

apoorvatarafdar8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE  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 
Comparator Agent  Intubation prediction score  An observational score of 3 parameters namely Mallampatti grading, Atlanto-occipital joint extension measured by a goniometer and mandibular length will be implemented pre operatively in all patients recruited for the study and the prediction of difficulty of endotracheal intubation will be done by calculating the total score. This will be followed by endotracheal intubation intraopertively in which actual difficulty of intubation will be assessed. Following this the sensitivity specificity and positive and negative predictive value will be assessed for the scoring system 
Comparator Agent  Wilson’s score  An observational score of 5 parameters namely weight, head and neck movement, jaw movement, receding mandible and buck teeth will be implemented pre operatively in all patients recruited for the study and the prediction of difficulty of endotracheal intubation will be done by calculating the total score. This will be followed by endotracheal intubation intraopertively in which actual difficulty of intubation will be assessed. Following this the sensitivity specificity and positive and negative predictive value will be assessed for the scoring system 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients willing to sign informed consent.
2. Patients between ages of 18 to 60 years.
3. Patients posted for elective surgeries under general anaesthesia requiring
endotracheal intubation
 
 
ExclusionCriteria 
Details  1. Patients unwilling to participate in the study.
2. Patients with previous history of trauma to airway.
3. Patients undergoing emergency surgery.
4. Patients having tumors or mass in the laryngeal, facial and cervical region or
any other gross abnormalities of head and neck region.
5. Patients having any cervical spine pathology 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the sensitivity, specificity, positive predictive value and accuracy of intubation prediction score versus Wilsons score for predicting difficult endotracheal intubation   Assessment of parameters as per Wilsons score and intubation prediction score pre operatively in all patients for predicting difficult endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Relatively more accurate prediction of difficult intubation and avoidance of unanticipated difficult airway  Assessment of parameters as per Wilsons score and intubation prediction score pre operatively in all patients for predicting difficult endotracheal intubation  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/01/2025 
Date of Study Completion (India) 01/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Introduction
 Prediction of difficult airway is of utmost importance to anaesthesiologist in the operating room as an unanticipated difficult airway leads to severe adverse events. Prediction of difficult airway is clinically done by independent bedside tests but lack accuracy. Moreover, most airway assessment scores are cumbersome to perform at the bedside and have interobserver variability because of subjective parameters. Therefore, there is a need to search for a simple score with objective parameters that can be performed at the bedside. 
Aim: 
To determine the diagnostic accuracy of the Wilson score and Intubation prediction score for predicting difficult airway.
Materials and Method: 
A prospective single-blind study will be conducted involving 120 consecutive patients aged 18 to 60 years who are undergoing surgery requiring general anaesthesia with endotracheal intubation. All patients will have their airways evaluated preoperatively using the Wilson Score and Intubation Prediction Score. General anaesthesia with endotracheal intubation will be performed on all participants. The ease of laryngoscopy and intubation will be assessed using the Intubation Difficulty Scale, where an IDS score greater than 5 indicates a difficult airway. In this study we will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of the two predictive tests for identifying a difficult airway.
 
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