| CTRI Number |
CTRI/2024/06/068772 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries. |
|
Scientific Title of Study
|
A prospective randomised study
Comparing clinical performance of AMBU AURAGAIN and LMA
BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries. |
| 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 Sweta |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smriti Garg |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College Meerut |
| Address |
Department of Anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9410617435 |
| Fax |
|
| Email |
dr250317@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology LLRM Medical college Meerut Uttar Pradesh India 250004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
LLRM Medical College Meerut Uttar Pradesh India 250004 |
| 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 Sweta |
LLRM medical college |
Department of anaesthesiology LLRM Medical college Meerut UTTAR PRADESH 250004
Meerut
UTTAR PRADESH |
8750933442
swetaanae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA Grade I and Grade II undergoing general anaesthesia for elective surgeries |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMBU AURAGAIN |
Laryngeal Mask Airway(LMA), single use made of phthalate free Poluvinyl Chloride(PVC). It is anatomically curved Supra glottic Airway Device(SGAD) which incorporates 90 degrees preformed curvature to approximate airway anatomy which aids in ventilation during general anaesthesia for surgeries less than 2 hrs duration. |
| Comparator Agent |
LMA BLOCKBUSTER |
LMA reusable made up of silicone increasingly used for cases of difficult intubation. It has a short airway tube which has 95degrees angulation to match oropharyngeal curve and a guidance device for successful blind intubation. |
| Intervention |
SUPRAGLOTTIC AIRWAY DEVICE Insertion |
Group of airway devices that can be inserted into the pharynx to allow ventilation, oxygenation, and administration of anaesthetic gases, without the need for endotracheal intubation. duration less than 2 hrs surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and grade II Patients.
2. Age- 18 to 65 years of either sex.
3. Patients undergoing surgery under general anaesthesia.
4. Anticipated normal airway in preanaesthetic evaluation.
5. Posted for surgery requiring supine position only |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Anticipated high risk of aspiration (hiatus hernia, full stomach, pregnancy, gastro-oesophageal reflux).
3. Preoperative respiratory tract infection.
4. Patients with history of allergy or sensitivity to any medication, latex or egg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal seal pressure(OSP) |
Once after insertion of supraglottic airway device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts taken |
For successful insertion of device |
| Time taken for effective insertion |
Upto securing the airway |
| Ease of insertion of device and gastric tube placement |
During insertion of device |
| Hemodynamic parameters (BP, HR, SPO2) |
Baseline, every 5 minutes for initial 15 minutes and then every 15 minutes till end of the surgery. |
| Post-op complications (Displacement, blood staining, Sore throat, hoarseness, injury) |
After extubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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="2"
Months="0"
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
|
It is a prospective randomised study comparing clinical performance of AMBU AURAGAIN and LMA BLOCKBUSTER in adult patients undergoing general anaesthesia for elective surgeries of less than 2 hrs duration. |