| CTRI Number |
CTRI/2022/06/043325 [Registered on: 17/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Blockbuster LMA versus Videolaryngoscope for tracheal intubation. |
|
Scientific Title of Study
|
Comparison of Blockbuster Laryngeal Mask Airway versus Videolaryngoscope for Tracheal Intubation; A randomized interventional study at SMS Medical College, Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College ,Jaipur |
| Address |
Department of Anesthesiology, Sawai Man Singh Medical College and Attached Hospital, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414398827 |
| Fax |
|
| Email |
Reemadrrn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Meena |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College,Jaipur |
| Address |
Department of Anesthesiology, Sawai Man Singh Medical College and Attached Hospital, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414398827 |
| Fax |
|
| Email |
Reemadrrn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aayushi Mudgal |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College, Jaipur |
| Address |
SMS Medical College and Hospitals Jaipur.
A-208,Madhav Nagar,Lane-2,Chourasiyawas Road, Ajmer
Ajmer
RAJASTHAN
302004
India |
| Phone |
9509395630 |
| Fax |
|
| Email |
dr.aayushi.mudgal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh Medical College and attached Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Sawai Man Singh Medical College and attached Hospital Jaipur |
| Address |
JLN Marg, Adarsh Nagar, Jaipur |
| 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 |
| Dr Reema Meena |
Sawai Man Singh Medical College |
Department of Anaesthesia,SMS Medical College, Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN |
09414398827
Reemadrrn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee |
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 |
Intubating Laryngeal Mask Airway |
Blockbuster Laryngeal Mask Airway which is an intubating laryngeal mask airway is used for tracheal intubation at the time of induction in elective surgeries under general anesthesia |
| Intervention |
Videolaryngoscope |
Videolaryngoscope used for tracheal intubation at the time of induction in elective surgeries under general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Weight-40-80kg
2)ASA physical status 1-3
3)Undergoing elective surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1)Known/predicted difficult airway
2)Patients with some airway pathology(Mass,Infections)
3)Negative patient consent
4)NBM<6hours
5)Mouth opening less than 3cm |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Time |
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)First attempt success rate.
2)No.of intubation attempts
3)Insertion Time
4)Hemodynamic parameters(BP,Heart rate,spo2,Mean arterial pressure)
4)Complications
|
7 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/07/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized controlled study is conducted to find out which medical device (Videolaryngoscope or Blockbuster Laryngeal Mask Airway) is better in achieving shorter intubation time, more first attempt success ,less no. of attempts ,stable post intubation hemodynamics, better ease of insertion and lesser complications. |