| CTRI Number |
CTRI/2025/07/091997 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intubation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of Standard and Video-Guided Breathing Tube Insertion Through the Nose in Patients with Difficult Airways |
|
Scientific Title of Study
|
Comparison of Fiberoptic Nasal Intubation versus Video-Assisted Fiberoptic
Nasal Intubation in Patients with Anticipated Difficult Airway:A Randomized
Comparative 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 |
Gokul G |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bathinda |
| Address |
No.145, Department Of Anaesthesiology and Critical Care, 1st Floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
No.145, Department Of Anaesthesiology and Critical Care, 1st floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
Bathinda
PUNJAB
151001
India |
| Phone |
9080277557 |
| Fax |
|
| Email |
gokulgovy99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Grewal |
| Designation |
Head Of the Department, Anaesthesiology |
| Affiliation |
AIIMS, Bathinda |
| Address |
No.145, Department Of Anaesthesiology and Critical Care, 1st Floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
No.145, Department Of Anaesthesiology and Critical Care, 1st Floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
Bathinda
PUNJAB
151001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Grewal |
| Designation |
Head Of the Department, Anaesthesiology |
| Affiliation |
AIIMS, Bathinda |
| Address |
No.145, Department Of Anaesthesiology and Critical Care, 1st Floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
No.145, Department Of Anaesthesiology and Critical Care, 1st Floor D block,All India Institute Of Medical Sciences,Bathinda, Mandi Dabwali Road
Bathinda
PUNJAB
151001
India |
| Phone |
9815482626 |
| Fax |
|
| Email |
dranjugrewal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gokul G |
| Address |
Mandi Dabwali Road, AIIMS Bathinda,Punjab |
| Type of Sponsor |
Other [Self] |
|
|
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 Gokul G |
AIl India Institute Of Medical Sciences |
No.145,Department Of Anaesthesiology and Critical Care,1st floor D block
Bathinda
PUNJAB |
9080277557
gokulgovy99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fiberoptic Nasal Intubation |
Total time taken |
| Intervention |
Videolaryngoscopy with Fiberoptic Nasal Intubation |
Total time taken |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA1,2and 3 patients aged more than or equal to 18 yrs
2)Anticipated difficult airway(El Ganzouri Risk Index score more than or equal to 7) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total time taken for intubation of trachea with Endotracheal tube in Fiberoptic
nasal intubation and Video Assisted Fiberoptic Nasal Intubation in patients with anticipated
difficult airway. |
The total time taken for intubation will be
noted from the time when the mask is removed from the patient till the appearance of six regular
continuous square waves of capnogram. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess the need for additional manoeuvres in the first attempt (jaw thrust, optimal external
laryngeal manipulation & ETT rotation at the level of glottis during ETT insertion)
2) To compare the first pass success rate in the two techniques.
3) To compare the ease of operator during intubation in the two techniques. |
Intra operatively,After pre oxygenation, from the time the oxygen face mask is being removed till appearance of 6 continuous capnographic waves after nasal intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/08/2025 |
| 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="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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gokulgovy99@gmail.com].
- For how long will this data be available start date provided 30-06-2025 and end date provided 12-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present study focuses on comparing the time taken for intubation of trachea via fiberoptic nasal intubation versus Videolaryngoscopic Assisted Fiberoptic Intubation(VAFI) in patients with anticipated difficult airway. We hypothesize that the VAFI technique is equivalent to fiberoptic nasal intubation when used as a sole technique in patients with anticipated difficult airway. |