CTRI Number |
CTRI/2025/04/084598 [Registered on: 11/04/2025] Trial Registered Prospectively |
Last Modified On: |
07/04/2025 |
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
|
“A Study on Nasal Intubation: With or Without a Bougie Using Video Laryngoscopy” |
Scientific Title of Study
|
“A randomized controlled study to evaluate Nasotracheal intubation using video laryngoscope with a bougie versus without a bougie in Department of Anaesthesia , SMS Medical college, Jaipur . |
Trial Acronym |
CAB |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajni Mathur |
Designation |
Senior professor |
Affiliation |
Swai Man Singh Medical College and Hospital |
Address |
Department of Anaesthesiology Swai Man Singh Medical College and hospital jaipur Rajasthan india
Jaipur RAJASTHAN 302004 India |
Phone |
9829357194 |
Fax |
|
Email |
rajnimathur@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajni Mathur |
Designation |
Senior professor |
Affiliation |
Swai Man Singh Medical College and Hospital |
Address |
Department of Anaesthesiology Swai Man Singh Medical College and hospital jaipur Rajasthan india
Jaipur RAJASTHAN 302004 India |
Phone |
9829357194 |
Fax |
|
Email |
rajnimathur@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Lalita |
Designation |
Resident Doctor |
Affiliation |
Swai Man Singh Medical College and hospital |
Address |
Deparment of Anaesthesiology Swai Man Singh Medical College and hospital jaipur Rajasthan india
Jaipur RAJASTHAN 302004 India |
Phone |
9057294674 |
Fax |
|
Email |
lalitabijarniya1@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology , Swai Man Singh medical college and hospital , Jaipur Rajasthan 302004 india |
|
Primary Sponsor
|
Name |
Swai Man Singh medical college and hospital Jaipur |
Address |
Department of Anaesthesiology Swai Man Singh Medical College and hospital jaipur Rajasthan 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 |
Dr Rajni Mathur |
Swai Man Singh medical college and hospital |
Operation Theatre Department of Anaesthesiology Sawai Man Singh Medical College and hospital Jaipur Rajasthan India Jaipur RAJASTHAN |
9829357194
rajnimathur@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Office of Ethics committee, SMS Medical College and hospital, Jaipur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Bougie-Assisted Nasotracheal Intubation using Video Laryngoscope |
A bougie (endotracheal tube introducer) is used to guide the endotracheal tube through the nasal passage and glottis under visualization with a video laryngoscope.
• After visualizing the glottis with the video laryngoscope, the bougie is inserted through the nostril, navigated into the trachea, and then the endotracheal tube is railroaded over the bougie.
• The bougie provides tactile feedback (“clicks” or “hold-up”) confirming tracheal placement, improving success rates, especially in anatomically challenging airways.
• This method is intended to improve first-attempt success, increase intubation time, and minimise airway trauma. |
Comparator Agent |
Standard Nasotracheal Intubation using Video Laryngoscope without a Bougie |
In this method, nasotracheal intubation is performed directly using a video laryngoscope without the use of a bougie or introducer.
• The endotracheal tube is inserted through the nostril and guided into the trachea under direct visualization using the video laryngoscope.
• This is the conventional technique commonly used in clinical settings.
• It may require more manipulation, head positioning, or external pressure to align the airway. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1.Patients posted for elective surgery under general Anaesthesia and requiring Nasotracheal intubation.
2.Patients consenting to participate.
3.Adult Patients aged 18-50 yrs.
4.Patients belonging to ASA grade I & II |
|
ExclusionCriteria |
Details |
1.Patients with anticipated difficult airway.
2.MPG 1 is III & IV
3.BMI Grater than 35 kg/m².
4.Pregnancy.
5.Full stomach,nasal deformity. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1.Mean time of intubation
2.Proportion of cases having ease of intubation.
3.Proportion of cases needing external manoeuvres.
4.Proportion of cases having complications like trauma and hoarseness of voice. |
1.Mean time of intubation immediately during the intubation procedure
2.Proportion of cases having ease of intubation.
3.Proportion of cases needing external manoeuvres.
4.Proportion of cases having complications like trauma and hoarseness of voice. |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
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)
|
25/04/2025 |
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="0" Months="2" 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 study aims to compare nasotracheal intubation (NTI) using a video laryngoscope (VL) with a bougie versus without a bougie. Patients will be randomly assigned to either group, and key outcomes such as first-attempt success rate, intubation time, number of attempts, and complications (e.g., epistaxis, mucosal trauma) will be evaluated. The study will help determine whether using a bougie improves the success and safety of NTI with Video laryngoscope.
|