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CTRI Number  CTRI/2025/08/092254 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To assess how two scores used for rating the difficulty in passing an oral tube for anaesthesia agree between two assessors 
Scientific Title of Study   A prospective observational pilot study for the assessment of inter-rater agreement/ reliability of the Fremantle and VCI scores in cancer patients undergoing videolaryngoscopic orotracheal intubations at a tertiary care oncological centre 
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 Jeson R Doctor 
Designation  Professor 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Room No 210, Department of Anaesthesia, Critical Care and Pain,2nd floor, Main building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820054956  
Fax    
Email  jesonrdoctor@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jeson R Doctor 
Designation  Professor 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Room No 210, Department of Anaesthesia, Critical Care and Pain,2nd floor, Main building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9820054956  
Fax    
Email  jesonrdoctor@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suriyaprakash Nedunchezhian 
Designation  PG Student 
Affiliation  Tata Memorial Hospital, HBNI 
Address  Room No 210, Department of Anaesthesia, Critical Care and Pain,2nd floor, Main building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  6374945236  
Fax    
Email  nsp1712@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain,Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Room No 210, Department of Anaesthesia, Critical Care and Pain,2nd floor, Main building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai- 400012 
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 
Dr Jeson R Doctor  Tata Memorial Hospital  Room No 210, Department of Anaesthesia, Critical Care and Pain,2nd floor, Main building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA 
9820054956

jesonrdoctor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee  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 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion Criteria-
1) Adult patients requiring Orotracheal intubation for Elective surgery in an Operating Room Setting.
2) ASA 1, 2, 3 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1) Use of Awake Technique for securing the airway
2) Inadequate mouth opening less than 1 finger, not permitting introduction of VL blade 3) Distal airway obstruction compressing the central airway like a large thyroid mass, Vocal cord lesions and neck masses compressing the airway. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the inter-rater agreement of the Fremantle scores rated by Anaesthesiology consultants (Airway expert panel) with each other.  Anytime between 48 hours to 1 week after successful intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the inter-rater agreement of the VCI scores rated by Anaesthesiology consultants (Airway expert panel) with each other  Anytime between 48 hours to 1 week after successful intubation 
To Assess the Inter-rater reliability/ agreement of the Fremantle scores recorded by the trainee with the scores recorded by the experts (consultants).  Anytime between 48 hours to 1 week after successful intubation 
To Assess the Inter-rater reliability/ agreement of the VCI scores recorded by the trainee with the scores recorded by the experts (consultants).  Anytime between 48 hours to 1 week after successful intubation 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   18/08/2025 
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="2"
Months="0"
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 - NO
Brief Summary  

The Glottic Visualisation is an important aspect of determining the difficulty in intubation in a direct laryngoscopy, as the direct line of sight corresponds to the direction of the tube during intubation. This was the principle in establishing the Cormack and Lehane Grading system and further modifications of it [1,2]-To give the subsequent airway operator an idea about the means and method of airway handling to be used. Hence an accurate and reproducible recording of laryngoscopic view at tracheal intubation is an important aspect of anaesthetic practice.

For Videolaryngoscopy a similar system was established by Levitan et al, The Percentage of Glottic Opening (POGO) score [3,11]. Unlike direct laryngoscopy, in which the view achieved by the line of sight directly relates to the ease of intubating the trachea, videolaryngoscopy can create a situation in which the view is good, but intubation is difficult or impossible as it offers an indirect view of the Glottis. A good or complete glottis view on Videolaryngoscopy does not essentially translate into an easy and successful intubation with a Videolaryngoscope [4,8].Videolaryngoscopy does not achieve a 100% intubation success rate, and complications have been associated with the procedure [5,6,7]. With videolaryngoscopy, the success of intubation lies not in the view obtained, but in the ease of inserting the endotracheal tube.

This has created the need for a different scoring system other than the standard Cormack Lehane Grading for direct laryngoscopic intubations or Levitan et al’s Percentage of Glottic Opening (POGO) Score. Any scoring system based solely on view does not adequately describe the issue encountered at videolaryngoscopy of a good view of the glottis but difficulty in intubation. The Fremantle and VCI scoring systems for Videolaryngoscopic intubation addresses these pitfalls.

The key to a successful outcome lies not in the view obtained but in the ease of inserting the endotracheal tube and this must be taken into account in any scoring system. If videolaryngoscopy is planned and a device has been previously documented to easily facilitate intubation at the first attempt then view obtained on the video screen is only a small part of the information that an anaesthetist wants to know. The Fremantle Score/VCI score is an attempt to improve the description of intubation by video laryngoscopes [9,10].

 
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