| CTRI Number |
CTRI/2021/09/036307 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
25/08/2021 |
| 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
|
Comparison of Ambu Auragain and LMA Proseal in patients posted for elective surgeries under general anaesthesia |
|
Scientific Title of Study
|
Comparison of the working performance of Ambu Auragain and LMA Proseal among the patients posted for elective surgeries: A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jugal Pankajbhai Shukla |
| Designation |
1st year resident, MD Anaesthesia |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T HOSPITAL BHAVNAGAR, GUJARAT- 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
7874092929 |
| Fax |
|
| Email |
jugalshukla25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lopa H Trivedi |
| Designation |
Associate Professor, Department Of Anaesthesiology |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T HOSPITAL BHAVNAGAR, GUJARAT- 364001
Bhavnagar
GUJARAT
364002
India |
| Phone |
9408009958 |
| Fax |
|
| Email |
trivedi_lopa@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jugal Pankajbhai Shukla |
| Designation |
1st year resident, MD Anaesthesia |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T HOSPITAL BHAVNAGAR, GUJARAT- 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
7874092929 |
| Fax |
|
| Email |
jugalshukla25@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
|
|
Primary Sponsor
|
| Name |
Government Medical College Bhavnagar |
| Address |
Government Medical College and Sir T Hospital Bhavnagar, Jail Road, Bhavnagar, Gujarat-364001 |
| 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 JUGAL PANKAJBHAI SHUKLA |
SIR T GENERAL HOSPITAL BHAVNAGAR |
DEPARTMENT OF ANAESTHESIOLOGY, SIR T HOSPITAL GENERAL BHAVNAGAR, GUJARAT
Bhavnagar
GUJARAT |
7874092929
jugalshukla25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Bhavnagar |
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 |
| Intervention |
Ambu Auragain |
2nd generation supraglottic airway device. Frequency and duration depends on type of surgery.(maximum 120 minutes) |
| Comparator Agent |
LMA Proseal |
2nd generation supraglottic airway device. Frequency and duration depends on type of surgery.(maximum 120 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
(1)Mouth opening <2 cm
(2)Mallampati class 4
(3)Body mass index (BMI) > 30 kg/m2
(4)Upper respiratory tract infection
(5)Increased risk of aspiration (not adequate NBM,
Gastro oesophageal reflex disorder, hiatus
hernia and pregnancy)
(6)Need for high airway pressure (COPD patients, Asthma)
(7)Cervical spine fracture or instability
(8)History of allergy to one or more drugs and latex |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Ambu Auragain & LMA Proseal in terms of no. of attempts required, time required for insertion, manipulation required after insertion, failed insertion, oropharyngeal leak pressure, mean tidal expiratory volume |
2-4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Ambu Auragain & LMA Proseal and in terms of
hemodynamic response in terms of Heart Rate (HR) & Mean Arteria Pressure (MAP) during insertion of SGA devices,
ease of insertion of gastric tube through SGA devices,
To compare complications like blood staining after removal, oropharyngeal pain |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
15/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking approval from ethics committee, study will be initiated on patients fulfilling inclusion criteria, patients will be compared for insertion success and working performance of supraglottic airway devices- Ambu Auragain and LMA Proseal in general anaesthesia in patient undergoing elective surgery. |