| CTRI Number |
CTRI/2023/07/055390 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Comparative study to evaluate the performance of Ambu Auragain and the Laryngeal Mask Airway Supreme |
|
Scientific Title of Study
|
A Randomised Comparative study to evaluate the performance of Ambu Auragain and the Laryngeal Mask Airway Supreme in Adult patients for Elective surgeries under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JSAnmol |
| Designation |
Post graduate in Anaesthesiology |
| Affiliation |
JJM Medical College |
| Address |
Department of Anaesthesiolo1st floor, Bapuji hospital
Seminar hall 1.
MCC B block
Kuvempu Nagar
Davangere
MCC B Block, Kuvempu Nagar
Davanagere
577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8197123168 |
| Fax |
|
| Email |
jsanmolpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSumaKV |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
JJM Medical College |
| Address |
Department of Anaesthesiology, 1st floor,Room 1, Bapuji hospital, beside JJM Medical College
MCC B block
Kuvempu Nagar
Davangere
MCC B Block, Kuvempu Nagar
Davanagere
577004
Davanagere
KARNATAKA
577004
India |
| Phone |
9886783103 |
| Fax |
|
| Email |
drsumakv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JSAnmol |
| Designation |
Post graduate in Anaesthesiology |
| Affiliation |
JJM Medical College |
| Address |
Department of Anaesthesiology, 1st floor, Room 1, Bapuji hospital, JJM Medical College,
MCC B Block, Kuvempu nagar
MCC B Block, Kuvempu Nagar
Davanagere
577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8197123168 |
| Fax |
|
| Email |
jsanmolpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| JJM Medical College
MCC B block
Kuvempu Nagar
Davangere
577004 |
|
|
Primary Sponsor
|
| Name |
JJM Medical College |
| Address |
MCC B Block
Kuvempu Nagar
Davanagere
577004 |
| 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 |
| JSAnmol |
Bapuji hospital |
Bapuji hospital, 1st floor OT complex,beside JJM Medical College.
MCC B Block
Kuvempu Nagar
Davanagere
Davanagere
KARNATAKA |
8197123168
jsanmolpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee JJM Medical College |
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 |
Insertion of Ambu Auragain |
Insertion of Supraglottic Airway Device, Ambu Auragain in patients undergoing elective surgery under general anaesthesia for duration of 30-120 minutes |
| Intervention |
Insertion of LMA Supreme |
Insertion of Supraglottic Airway Device,LMA Supreme in patients undergoing elective surgery under general anaesthesia for duration of 30-120 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Duration of surgeries less than 2 hours
ASA I and II
Posted for elective surgery under general anaesthesia in supine position |
|
| ExclusionCriteria |
| Details |
Patients with predicted difficult airway
Patients with any pathology in neck, upper respiratory or alimentary tract
BMI more than 30kg/me
Patients with history of obstructive sleep apnea,lung diseases or bleeding disorders
Patients with full stomach or history of oesophageal reflux
Pregnancy |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of attempts, time taken for insertion(in seconds) and ease of insertion
Oropharyngeal leak pressure(in cm H2O)
Ease of insertion of Nasogastric tube
Hemodynamic changes(heart rate, saturation and blood pressure)
|
Hemodynamic changes(heart rate, saturation and blood pressure)at 1min, 5min and 10 min after Supraglottic Airway Device insertion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative desaturation or laryngospasm
Blood stain on device during withdrawal
Postoperative sore throat, hoarseness or dysphagia |
1 hour and 6 hours postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Supraglottic Airway devices form a bridge between the mask and endotracheal intubation. Following the introduction of LMA , numerous advances have been made with respect to design and safety features. The LMA Supreme and Ambu Auragain are the new second generation SGADs having comparable features such as inflatable cuff, a preformed anatomical curvature facilitating easy insertion and a gastric port for Nasogastric tube insertion and produces high OLP facilitating positive pressure ventilation. Previous studies have reported conflicting results regarding performance of these 2 devices. We are conducting this study to compare insertion of the device, OLP, ease of NGT insertion, hemodynamic stability and complications. |