| CTRI Number |
CTRI/2024/07/069795 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing 3 types of video laryngoscopes to aid endotracheal intubation for surgeries under general anesthesia |
|
Scientific Title of Study
|
A Comparative Study Between King Vision Video Laryngoscope, Tascope, And Macintosh Laryngoscope For Endotracheal Intubation In Patients Undergoing Surgery Under General Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya MJ |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Department of Anaesthesiology Ground floor OT complex Sapthagiri institute of medical sciences & research centre No 15 Hesarghatta road Navy layout Chikkasandra
Bangalore
KARNATAKA
560090
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9481366992 |
| Fax |
|
| Email |
divyamj691@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya MJ |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Department of Anaesthesiology Ground floor OT complex Sapthagiri institute of medical sciences & research centre No 15 Hesarghatta road Navy layout Chikkasandra
Bangalore
KARNATAKA
560090
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9481366992 |
| Fax |
|
| Email |
divyamj691@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Babu |
| Designation |
PROFESSOR |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Dept of Anesthesiology Ground floor OT complex Sapthagiri institute of medical science & research centre 15 Hesarghatta road Navy layout Chikkasandra
Bangalore
KARNATAKA
560090
India
No 15 Hesarghatta Road
Navy Layout Chikkasandra Chikkabanavara
Bangalore
KARNATAKA
560090
India |
| Phone |
9900214064 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri institute of medical sciences and research centre
No 15 Hesarghatta road Navy layout Chikkasandra
Bangalore
KARNATAKA
560090
India |
|
|
Primary Sponsor
|
| Name |
SAPTHGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
| Address |
No 15 Hesarghatta Road
Navy layout Chikkasandra
Bangalore
KARNATAKA
560090
India |
| 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 Divya MJ |
Sapthagiri institute of medical sciences & research centre |
Department of anaesthesiology OT complex Ground floor No 15 Chikkasandra Hesarghatta main road Bengaluru 560090
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9481366992
divyamj691@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical sciences and research centre institutional ethics committe |
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 |
King Vision Video Laryngoscope |
Use of King Vision Video Laryngoscope as device to facilitate intubation during General anaesthesia.The insertion of this device takes few seconds only. As soon as this is inserted and glottis is visualised endotracheal tube is inserted into the trachea.Time taken for intubation and success rate in first attempt will be assesed. The whole procedure takes less than a minute time .Patient will be assesed for ten minutes after the procedure. |
| Comparator Agent |
Macintosh Laryngoscope |
MACINTOSH is a device to facilitate intubation during general anaesthesia. This is goal standard method used for intubation on insertion of the blade as soon as glottis is visualised endotracheal tube is inserted to the trachea. Time taken for the intubation will be assessed patient will be assessed for the 10 minutes after the procedure. |
| Intervention |
The Anaesthetist Society Scope(TASCOPE) |
Use of TASCOPE as device to facilitate intubation during General anaesthesia.The insertion of this device takes few seconds only. As soon as this is inserted and glottis is visualised endotracheal tube is inserted into the trachea.Time taken for intubation and success rate in first attempt will be assesed. The whole procedure takes less than a minute time .Patient will be assesed for ten minutes after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent
2.ASA grade 1&2
3.Age 18 to 50 years
4.BMI of 18 to 24 kg/m2 |
|
| ExclusionCriteria |
| Details |
1.Patients who are not wiiling to participate in the study
2.Patients with difficult intubation & difficult mask ventilation
3.Patients with cervical instability
4.Pregnant females |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Asessment of ease of intubation and timetaken for intubation |
from the time of insertion of blade to definitive EtCO2 graphic representation on the monitor which is usually 30-60 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| determine 1st attempt success rate |
from the time of insertion of blade in 1st attempt till a definitive EtCO2 graphic representation on the monitor is obtained which is usually 30seconds -2 minutes |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - Clinical Study Report
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to email ID to be provided divyamj691@gmail.com
- For how long will this data be available start date provided 31-07-2025 and end date provided 30-07-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a study comparing three airway devices used for intubation in patients under General anesthesia. The three devices used in this study have been designed with certain minute variations but serves the same purpose of being highly beneficial in situations of difficult airway, in patients with respiratory infections & in COVID 19 patients. The major difference among them is their cost difference . Hence in our study we will be able to evaluate the efficacy and superiority of one device over the other . This will also enable us to asess their cost effectiveness. If we find in our study the indian model device to be safe and effective then that can be the trendsetter and can be utilised in future especially in resource limited settings and developing countries . |