| CTRI Number |
CTRI/2019/09/021044 [Registered on: 03/09/2019] Trial Registered Prospectively |
| Last Modified On: |
02/09/2019 |
| 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
|
Comparison of 2 different videolaryngoscopes in patients under general anaesthesia |
|
Scientific Title of Study
|
Comparison of Airtraq and McGrath videolaryngoscope for endotracheal intubation in simulated cervical spine injury patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Jain |
| Designation |
Post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive care MAMC and Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
8826378510 |
| Fax |
|
| Email |
13shwetajain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bhadoria |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive care MAMC and Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
09968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Bhadoria |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive care MAMC and Lok Nayak Hospital
New Delhi
DELHI
110002
India |
| Phone |
09968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Intensive care MAMC and LNH New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and LNH New Delhi 110002 |
| Type of Sponsor |
Government 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 |
| Shweta Jain |
Lok Nayak Hospital |
Department Of Anaesthesiology and Intensive care MAMC and Lok Nayak Hospital
New Delhi
DELHI |
8826378510
13shwetajain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To be posted for elective surgery under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation with Airtraq and McGrath videolaryngoscope in simulated cervical spine injury patients under general anaesthesia |
After adequate NPO, pt shifted to OT and all standard ASA monitors attached. A standard anaesthesia protocol followed. Anaesthesia will be induced and pt will be intubated |
| Comparator Agent |
Time taken for intubation
First attempt success rate
Overall success rate of intubation
Changes in haemodynamic variables
Incidence of desaturation and complications |
Time taken for intubation will be the primary outcome.
Percentage of patients having successful intubation on first attempt.
Haemodynamic parameters will be recorded every 1minute till 10mins after intubation.
Incidence of de saturation during tbe procedure and complications will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA1and 2 patients aged 18-60 years of either sex undergoing elective surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Mouth opening less than 2.5cm
Patient with any oral cavity pathology
Patient with cervical spine pathology
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation |
Time taken for intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
Percentage if patients having successful endotracheal intubation on first attempt |
| Overall success rate of intubation |
Overall percentage of patients in which successful endotracheal intubation will be donw |
| Changes in haemodynamic parameters |
HR and MAP will be noted just before application of MILS and then every 1minute till 10minutes after endotracheal intubation |
| Incidence of desaturation |
During the procedure if saturation goes below 94% in any of the patients |
| Incidence of complications |
Blood on airway device or ETT and incidence of sore throat after 2hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/09/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Airway management in cervical spine injury patients is challenge for Anaesthesiologist. Tracheal intubation without neck immobilization can result in devastating outcome and it becomes more difficult to visualize glottic opening using conventional laryngoscopy. Specialized devices like videolaryngoscopes have come for airway management. Airtraq is a channeled VL. It has exaggerated curvature of blade and an internal arrangement of optical components which provides high quality view of glottis without the need for alignment of oral, pharyngeal and laryngeal axis. McGrath is a non channeled VL with handle, camera stick and blade |