| 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
|
|
|
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
|
|
|
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. |