| CTRI Number |
CTRI/2026/02/103671 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two video-guided techniques for nasal breathing tube placement in patients undergoing jaw and facial surgery, assessing first-atempt success. |
|
Scientific Title of Study
|
Comparison of the use of Video Laryngoscope vs Video Laryngoscope aided with Flexible scope as an intubation aid for nasotracheal intubation in patients undergoing maxillofacial surgery- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anwesha Deori |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9613121556 |
| Fax |
|
| Email |
anwesha.deori@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan S |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
96226493045 |
| Fax |
|
| Email |
srinianaes@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasan S |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
96226493045 |
| Fax |
|
| Email |
srinianaes@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund
Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu, Dhanvanthri Nagar, Puducherry, PIN- 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER campus road, Gorimedu, Dhanvantari Nagar, Puducherry- 605006, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Anwesha Deori |
Jawaharlal institute of post graduate medical education and research |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY |
09613121556
anwesha.deori@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- INTERVENTIONAL STUDIES JIPMER, PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Video laryngoscope combined with flexible scope intubation |
Nasotracheal intubation will be attempted under guidance of video laryngoscope combined with flexible scope. After induction of general anesthesia patients will be ventilated with bag and mask using one hundred percent oxygen for three minutes. A vasoconstrictor and a local anesthetic agent will be applied to the nostril before intubation. The ambuscope preloaded with the endotracheal tube will be inserted through the selected nostril under video laryngoscope guidance to obtain a clear view of the vocal cords. The flexible scope will be guided into the trachea and then the tracheal tube will be advanced. Successful intubation will be confirmed by appearance of end tidal carbon dioxide. The duration of the intervention will be defined as the time from insertion of the video laryngoscope into the oral cavity until confirmation of successful endotracheal intubation by appearance of end-tidal carbon dioxide. A failed attempt will be defined as inability to intubate the patient with fall of O2 saturation below 90%. |
| Comparator Agent |
Video laryngoscope intubation only |
Nasotracheal intubation will be performed using only video laryngoscope. After induction of general anesthesia patients will be ventilated with bag and mask using one hundred percent oxygen for three minutes. The endotracheal tube will be inserted through the selected nostril and nasotracheal intubation will be attempted under video laryngoscopic guidance. Magill forceps will be used if required to guide the tube towards the glottis. Successful intubation will be confirmed by appearance of end tidal carbon dioxide. The duration of the intervention will be defined as the time from insertion of the video laryngoscope into the oral cavity until confirmation of successful endotracheal intubation by appearance of end-tidal carbon dioxide. A failed attempt will be defined as inability to intubate the patient with fall of O2 saturation below 90%. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for maxillofacial
surgeries requiring general anaesthesia with nasotracheal intubation
2. Adult patients aged 18 to 60 years undergoing nasotracheal intubation for
maxillofacial surgery
3. American Society of Anaesthesiologists (ASA) status 1, 2 or 3
|
|
| ExclusionCriteria |
| Details |
1.Patients with restricted mouth opening
2.Patients planned for awake fibreoptic intubation.
3.Patients having any contraindications to
nasotracheal intubation-
Suspected epiglottitis
Midface instability
•Coagulopathy
•Suspected basilar skull fracture
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the success rate of first attempt of
nasotracheal intubation between ‘VL-FS Group’ and ‘VL-Only Group’
VL-FS Group- Video laryngoscope combined with Flexible scope intubation
VL-Only Group- Video laryngoscope intubation only
|
First, baseline vitals will be recorded for the patient after shifting to OT.
Second after first attempt successful intubation— measured from insertion of device till confirmation by capnography.
Third, if first attempt failed and more attempts were required and if there was any change in technique.
All assessments will be done intra-operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the number of attempts for successful nasotracheal intubation between VL-FS group & VL-Only group.
2.To compare the time to successful intubation which is time taken from passing blade to cuff inflation of endotracheal tube between VL-FS group & VL-Only group.
3.To compare the ease of intubation between VL-FS group & VL-Only group.
|
All secondary outcomes will be assessed intraoperatively during the intubation procedure immediately after induction of anesthesia.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/02/2026 |
| 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 Yet Recruiting |
| 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
|
This randomized controlled trial aims to compare the effectiveness of video laryngoscope assisted with flexible scope versus video laryngoscope alone for nasotracheal intubation in adult patients undergoing maxillofacial surgery under general anaesthesia. Sixty patients will be randomly allocated into two groups. The VL-FS group will undergo nasotracheal intubation using a video laryngoscope combined with a flexible scope, and the VL-Only group will undergo intubation using a video laryngoscope alone. The primary outcome will be the time to successful intubation. Secondary outcomes will include first attempt success rate, number of attempts, ease of intubation and incidence of airway related complications. The study aims to determine whether the addition of a flexible scope improves intubation performance and safety during nasotracheal intubation. |