| CTRI Number |
CTRI/2019/04/018497 [Registered on: 09/04/2019] Trial Registered Prospectively |
| Last Modified On: |
05/04/2019 |
| 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
|
A research to compare two medical devices used for securing the airway of the patients under general anaesthesia in laparoscopic surgeries of the gall bladder stones. |
|
Scientific Title of Study
|
Comparison of ventilatory efficacy and airway dynamics between BlockBuster supraglottic airway device and endotracheal tube in patients undergoing laparoscopic cholecystectomy: a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshdeep Kaur |
| Designation |
Post graduate junior resident |
| Affiliation |
Government medical college and hospital,sector 32, Chandigarh |
| Address |
Department of Anaesthesia and intensive care,
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
8360081819 |
| Fax |
|
| Email |
randhawa.arsh1406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and intensive care,
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and intensive care,
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital,sector 32, Chandigarh |
|
|
Primary Sponsor
|
| Name |
GMCH |
| Address |
Government medical college and hospital, sector 32, Chandigarh |
| 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 |
| Arshdeep Kaur |
Government medical college and hospital, sector 32, Chandigarh |
Department of Anaesthesia and intensive care, D block, Level 5, GMCH, sector 32
Chandigarh
CHANDIGARH |
8360081819
randhawa.arsh1406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BlockBuster laryngeal mask airway |
Airway device to be used for securing airway during general anaesthesia. |
| Comparator Agent |
Endotracheal tube |
Airway device to be used for securing airway during general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 or 2.
Patients scheduled for elective laparoscopic cholecystectomy surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with anticipted difficult airway.
Patients with upper respiratory tract infection.
Patients with increased risk of regurgitation and aspiration of gastric contents.
Patients with a body mass index > 35kg/m2.
Patients with past history of radiotherapy to the neck involving the hypopharynx.
Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ventilatory parameters (peak airway pressure, plateau pressure, mean airway pressure, inspiratory and expiratory tidal volume, inspiratory and expiratory minute ventilation, inspiratory expiratory ratio, compliance, airway resistance,end tidal carbon dioxide) |
After intubation/Supraglottic airway device placement, before carboperitoneum, after carboperitoneum, at 10 minutes after position, after release of carboperitoneum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (non invasive blood pressure[systolic, diastolic, mean arterial pressure], heart rate, oxygen saturation. |
Baseline, after induction, after intubation/Supraglottic airway device placement, before carboperitoneum, after carboperitoneum, at 10 minutes after position, after release of carboperitoneum, after extubation/Supraglottic airway device removal |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/04/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, randomised, parallel group, active controlled trial where two devices, Blockbuster supraglottic airway device and Endotracheal tube, will be used for securing the patency of the airway during general anaesthesia and will be compared in terms of ventilatory parameters and airway dynamics in laparoscopic cholecystectomy surgeries. Secondary outcome will measure hemodynamic parameters between the two devices. |