| CTRI Number |
CTRI/2024/07/070021 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| 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
|
Which laryngoscope is better (conventional or video)to intubate in head injury patients by using propofol for induction |
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF CONVENTIONAL LARYNGOSCOPY AND VIDEO LARYNGOSCOPY ON HEMODYNAMIC PARAMETERS DURING INTUBATION IN HEAD INJURY PATIENTS USING PROPOFOL AS AN INDUCTION AGENT : A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Azeez Sabique T |
| Designation |
Postgraduate Student |
| Affiliation |
Rajasthan University of Health Sciences, Jaipur |
| Address |
Department of Anaesthesiology
Dr SN Medical college
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9847756575 |
| Fax |
|
| Email |
sabiquejamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr SN Medical college, Jodhpur |
| Address |
Department of Anaestheiology
Dr SN Medical college
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr SN Medical college, Jodhpur |
| Address |
Department of Anaestheiology
Dr SN Medical college
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Dr SN Medical college jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical college, Jodhpur |
| Address |
Dr SN Medical College, Sector D, Shasthri Nagar, Jodhpur, Rajasthan 342003 |
| 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 |
| Azeez Sabique T |
MDM hospital jodhpur |
Trauma center
MDM hospital campus
sector H
shasthri nagar, jodhpur
Jodhpur
RAJASTHAN |
9847756575
sabiquejamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr SN Medical college, jodhpur |
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 |
Conventional laryngoscopy Vs Video laryngoscopy |
In this study the efficacy of Conventional laryngoscopy using appropriate sized blade and endotracheal tube is compared with that of Video laryngoscopy in securing airway in terms of heart rate, mean arterial pressure, Time to visualize glottis, Cormack and Lehane grading, time taken for securing airway, Ease of intubation using Likert scale and Number of attempts used for intubation will be compared. |
| Intervention |
Video laryngoscopy Vs conventional laryngoscopy |
In this study i will be comparing the efficacy of Video laryngoscopy and conventional laryngoscopy in securing airway in terms of heart rate, mean arterial pressure, Time taken to visualize glottis, Cormack and Lehane grading, Time taken for securing airway, Ease of intubation using Likert scale and Number of attempts used for intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with traumatic head injury and GCS less than or equal to 8 and presenting within 24 hours of injury |
|
| ExclusionCriteria |
| Details |
Multiple trauma or injuries and already intubated and revisit for same injury and bilateral fixed and dilated pupils and history of cardiovascular diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the changes in heart rate and mean arterial pressure during intubation in head injury patients using video laryngoscope and conventional laryngoscope with propofol as induction agent |
baseline at the time of presentation, before premedication, after premedication, after induction, at insertion of laryngoscope, at insertion of endotracheal tube, 1,5,10,15 mins after insertion of endotracheal tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Time to visualise the glottis
2 Cormack & Lehane grading
3 The time taken for securing the airway
4 Ease of intubation using Likert scale
5 The number of attempts used for intubation |
At the time of laryngoscopy
& endotracheal intubation |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 - NO
|
|
Brief Summary
|
The aim of the study is to compare the efficacy of video laryngoscope and conventional laryngoscope on the hemodynamic parameters during intubation in head injury patients using propofol as induction agent.
Primary objective is to measure the changes in heart rate and mean arterial pressure during intubation in head injury patients using video laryngoscope and conventional laryngoscope with propofol as induction agent
secondary objectives are time to visualise the glottis, cormack and Lehane grading, the time taken for securing the airway ,ease of intubation using Likert scale and the number of attempts used for intubation |