| 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
|
|
|
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
|
|
|
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]. |