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CTRI Number  CTRI/2024/06/069693 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Analysis of Nasotracheal Intubation: Macintosh vs BPL Video Laryngoscope - A User-Friendly Approach vs Traditional Reliability 
Scientific Title of Study   Safety and efficacy of Macintosh Laryngoscope Vs Video Laryngoscope In Nasotracheal Intubation: A Prospective Randomized 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  Dr. Balasaheb Govardhane 
Designation  Associate Professor 
Affiliation  D.Y Patil Medical College, Navi Mumbai 
Address  Dept. Of Anesthesia, D.Y Patil Medical College and Hospital, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9819631719  
Fax    
Email  gbalasaheb690@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Balasaheb Govardhane 
Designation  Associate Professor 
Affiliation  D.Y Patil Medical College, Navi Mumbai 
Address  Dept. of Anesthesia, D.Y Patil Medical College and Hospital, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9819631719  
Fax    
Email  gbalasaheb690@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chinmay Divyadarshi kar 
Designation  Junior Resident 
Affiliation  D.Y Patil Medical College, Navi Mumbai 
Address  Dept. Of Anesthesia, D.Y Patil Medical College and Hospital, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  08637242255  
Fax    
Email  chinmay.d.kar@gmail.com  
 
Source of Monetary or Material Support  
Padmashree Dr. D.Y Patil Medical College and Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra, India Pin code: 400706 
 
Primary Sponsor  
Name  D.Y Patil Medical College and Hospital, Navi Mumbai 
Address  Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 
Type of Sponsor  Private 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 Chinmay Divyadarshi Kar  D.Y Patil Medical College and Hospital  Department of Anesthesia,2nd floor, OT Complex, D.Y Patil Medical College and Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 
8637242255

chinmay.d.kar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, D.Y Patil Deemed to be University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible, (2) ICD-10 Condition: M265||Dentofacial functional abnormalities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Direct Laryngoscope  Comparing the Video Larynoscopy BPL Laryngoscope with Direct Laryngoscope to compare the ease and efficacy in inubation 
Intervention  Video laryngoscope  Comparing the Video Larynoscopy BPL Laryngoscope with Direct Laryngoscope to compare the ease and efficacy in inubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients requiring nasotracheal intubation for surgical procedures, Patients with no prior history of difficult intubation or airway abnormalities that would contraindicate nasotracheal intubation 
 
ExclusionCriteria 
Details  Patients not willing to get enrolled in the study, Patients with history of cervical spine injury or instability, Patients with history of upper airway obstruction or upper airway anatomy abnormalities, Patient with ASA grading more than 3
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure will be the success rate of nasotracheal intubation, as determined by total time taken for intubation as mentioned in the primary objectives.  At Baseline, 1 minutes, 3 minutes and 5 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures will include the Cormack-Lehane grading system, intubation difficulty score assessment, hemodynamic changes (BP and HR) and any adverse events (trauma, failed intubation, technical snag etc)  1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 3 
Date of First Enrollment (India)   23/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  23/07/2024 
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)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Nasotracheal intubation is a commonly performed procedure in the operating room for oromaxillofacial and oral cancer surgery to secure the airway. Compared to oro-tracheal intubation, the intubation time are longer for naso-tracheal route and despite the optimal laryngeal views directing the tube into the trachea can be challenging and there is often the need of magill forcep to aid the intubation procedure.

The success of this procedure depends on the ability of the anesthesia provider to effectively visualize the glottis and secure a clear airway. Use of Macintosh laryngoscope remains a gold standard for Direct laryngoscopy for more than 50 years as it is easy to perform and master. In recent years, video laryngoscopy has emerged as an alternative to traditional direct laryngoscopy in nasotracheal intubation.

Video laryngoscopy provides a clear and magnified view of the glottis, which can be particularly beneficial in patients with difficult airways. This improved visualization can lead to a higher success rate of oro-tracheal intubation and a lower incidence of adverse events, such as failed intubation or esophageal intubation. However, there is limited data on the comparison between direct laryngoscopy and video laryngoscopy in nasotracheal intubation, and further research is needed to determine the benefits and limitations of each technique.

The purpose of this study is to compare the effectiveness, safety, and ease of use of direct laryngoscopy and video laryngoscopy in nasotracheal intubation. The study will assess factors such as intubation success rates, intubation times, and adverse events, and will provide important information to guide clinical decision making in this area

Overall, the literature suggests that video laryngoscopy can provide several benefits compared to direct laryngoscopy in nasotracheal intubation, including improved visualization, shorter intubation times, and improved ease of use. However, further research is needed to fully understand the benefits and limitations of this technique, and to determine the best patient populations and settings for its use.

 
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