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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  
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 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  
Status 
Not Applicable 
 
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.


 
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