| CTRI Number |
CTRI/2024/11/076847 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
video vs direct laryngoscopy by novice intubators |
|
Scientific Title of Study
|
Comparison of video laryngoscopy with direct laryngoscopy for endotracheal intubation by novice intubators in operation theater |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Yadav |
| Designation |
PG Student |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Dept of Anaesthesiology
Base Hospital
Delhi Cantt
South West
DELHI
110010
India |
| Phone |
7507320500 |
| Fax |
|
| Email |
drakash6513@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran S |
| Designation |
Professor |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Dept of Anaesthesiology
Base Hospital
Delhi Cantt
South West
DELHI
110010
India |
| Phone |
9810841725 |
| Fax |
|
| Email |
drkirans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran S |
| Designation |
Professor |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Dept of Anaesthesiology
Base Hospital
Delhi Cantt
DELHI
110010
India |
| Phone |
9810841725 |
| Fax |
|
| Email |
drkirans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Base Hospital
Delhi Cantt
India
Pin 110010 |
|
|
Primary Sponsor
|
| Name |
Akash Yadav |
| Address |
Base Hospital
Delhi Cantt
110010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Akash Yadav |
Base Hospital Delhi Cantt |
Resident Room
Operation Theater
Department of Anaesthesiology
South West
DELHI |
7507320500
drakash6513@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Base Hospital and Army College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct Laryngoscopy |
endotracheal intubation |
| Intervention |
Video Laryngoscopy |
endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elective Surgery
Fasting patients
ASA status I and II |
|
| ExclusionCriteria |
| Details |
Emergency Surgery
Non Fasting
ASA III and above |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intubation success
first attempt success
number of attempts
Time duration of intubation |
10 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
number of esophageal intubation
cormack Lehane grade
Percentage of glottis opening score
Use of optimization maneuvers
ease of use Vas scale
ease of use likert scale
Complications |
10 Minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drakash6513@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is Randomized, open label, parallel group, comparative single centre trial comparing video laryngoscopy with direct laryngoscopy by novice intubators in operation theater (PG anasthesia residents in 1st and 2nd year of training). The primary outcome measures will be Intubation success, first attempt success, number of attempts, number of esophageal intubation, cormack Lehane grade, time duration of intubation, percentage of glottis opening score, use of optimization maneuvers, Ease of use VAS scale, ease of use likert scale. |