| CTRI Number |
CTRI/2024/02/062559 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparing the efficacy of using two different devices in facilitating the artificial ventilation in patients by simulating cervical stabilization. |
|
Scientific Title of Study
|
To Compare the Efficacy of Using Video Laryngoscope against Airtraq Laryngoscope for Intubation in Patients by Simulating cervical Stabilization |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupanada Variyar Medical College and Hospital |
| Address |
OT complex,Department of Anesthesia,First floor,Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Seeragapadi,Salem
Vinayaka Missions Medical University
Seeragapadi
Salem
TAMIL NADU
636016
India |
| Phone |
09789092597 |
| Fax |
|
| Email |
Cpriyanka55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupanada Variyar Medical College and Hospital |
| Address |
OT complex,Department of Anesthesia,First floor,Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Seeragapadi,Salem
Vinayaka Missions Medical University
Seeragapadi
Salem
TAMIL NADU
636016
India |
| Phone |
09789092597 |
| Fax |
|
| Email |
Cpriyanka55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupanada Variyar Medical College and Hospital |
| Address |
OT complex,Department of Anesthesia,First floor,Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Seeragapadi,Salem
Vinayaka Missions Medical University
Seeragapadi
Salem
TAMIL NADU
636016
India |
| Phone |
09789092597 |
| Fax |
|
| Email |
Cpriyanka55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Seeragapadi,
Salem |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrPNaveena |
Associate Proffesor ,Department of Anesthesiology,Vinayaka Missions Kirupananda Variyar Medical College and Hospital,Seeragapadi,Salem,636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Naveena |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi |
Room number 15 Department of Anesthesiology
Salem
TAMIL NADU |
6382660052
Cpriyanka55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
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 |
| Intervention |
Comparison between two devices in facilitating artificial ventilation in patients |
Comparison between video laryngoscope and Airtraq laryngoscope for intubation in patients by simulating cervical stabilization |
| Comparator Agent |
Efficacy of using Airtraq laryngoscope |
Airtraq laryngoscope for intubation with estimated time less than 8 minutes |
| Comparator Agent |
Efficacy of using Video laryngoscope |
Video laryngoscope for intubation with estimated time less than 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients, Modified Mallampatti score 1-4,Modified Cormack Lehane score 1-4 |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4,Inter incisor distance less than 3 cm,Patients recognized as having difficult laryngoscope and intubation using preanesthetic evaluation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total intubation time and number of attempts
|
Within 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the glottic view need for external laryngeal manoeuvre hemodynamic changes |
Within 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/02/2024 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
The Study is aimed at comparing the ease, success and efficacy of using Video laryngoscope against Airtraq laryngoscope for intubation in patients by artificially simulating Cervical stabilization by Manual in line stabilization or by application of cervical collar to limit mouth opening and neck movement.50 adult patients posted for elective surgeries under General Anesthesia aged between 18-50 years belonging to ASA 1 and 2,Modified Mallampatti 1-4,Modified Cormack Lehane 1-4 chosen to be studied.Group A was allocated 25 patients for Airtraq laryngoscope and Group V was allocated 25 patients for Video laryngoscope. Hemodynamic variables like heart rate,blood pressure ,Oxygen saturation measured in all the patients. Number of intubation attempts,Number of operators,Number of alternative intubation techniques used,Glottic exposure ,Lifting force required for laryngoscope,Necessity of external laryngeal pressure and position of vocal cords at intubation recorded. |