| CTRI Number |
CTRI/2025/05/087223 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| 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
|
Comparision Between Blockbuster Laryngeal Mask Airway And Videolaryngoscope For Endotracheal Intubation |
|
Scientific Title of Study
|
A Randomized Comparative Study Between Blockbuster Laryngeal Mask Airway And Videolaryngoscope For Endotracheal Intubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyashi Maheshwari |
| Designation |
Resident anaesthesiology |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
09819663697 |
| Fax |
|
| Email |
priyashi.maheshwari11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Chahar |
| Designation |
professor |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
09413893218 |
| Fax |
|
| Email |
chaharvijay03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Chahar |
| Designation |
professor |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
09413893218 |
| Fax |
|
| Email |
chaharvijay03@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anesthesiology and critical care, pacific medical college and hospital,udaipur ,rajasthan-313001 |
|
|
Primary Sponsor
|
| Name |
PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR |
| Address |
Department of Anaesthesia and critical care , Pacific Medical College and Hospital, Bhilo Ka Bedla, Udaipur, Rajasthan-313001. |
| 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 priyashi maheshwari |
pacific medical college and hospital |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur
RAJASTHAN |
09819663697
priyashi.maheshwari11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee pacific medical college and hospital udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster laryngeal mask airway |
Intubation will be done via blockbuster LMA |
| Comparator Agent |
video laryngoscope |
Intubation will be done via videolaryngeoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patient giving informed consent.
patient undergoing elective surgeries under general anesthesia with endotracheal intubation.
ASA grade I and II.
patient weighing 40-80 kgs.
mallampati grade 3 and 4
|
|
| ExclusionCriteria |
| Details |
patient refusal.
patient with ASA grade III and above.
mallampati grade 3 and 4
patient with pharyngeal pathology and obstruction.
risk of aspiration e.g: pregnancy, gastroparesis etc.
anticipated difficult intubation.
patient with cervical spine injury. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of intubation, Intubation time, Number of intubation attempts between two groups |
intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
comparision of maneuver technique between video larngoscope and blockbuster laryngeal mask airway intubation.
comparision of hemodynamic variability between two groups
post intubation complication between two groups |
intraoperative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
27/05/2025 |
| 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 Yet Recruiting |
| 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
|
A Randomized Comparative Study Between Blockbuster Laryngeal Mask Airway And Videolaryngoscope For Endotracheal Intubation Is Done To Compare The Ease Of Intubation, Time Required For Intubation And Number Of Intubation Attempts.
|