| CTRI Number |
CTRI/2024/08/072617 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical comparative study between AMBU AURA 40 and BASKA mask in adult patient undergoing planned surgery |
|
Scientific Title of Study
|
A propespective randomised comparative evaluation of AMBU AURA 40 and BASKA mask airway in adult patient undergoing elective surgery. |
| 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 Vipin Kumar Dhama |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Medical College, Meerut, U.P. |
| Address |
Department of Anaesthesia, LLRM Medical college, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
97600014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin Kumar Dhama |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Medical College, Meerut, U.P. |
| Address |
Department of Anaesthesia, LLRM Medical college, Meerut
UTTAR PRADESH
250004
India |
| Phone |
97600014177 |
| Fax |
|
| Email |
drvipindhama@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Medical College, Meerut, U.P. |
| Address |
Department of Anaesthesia, LLRM Medical college, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
09423280996 |
| Fax |
|
| Email |
ajay10071993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ground floor G17
Department of Anesthesia
Lala Lajpat Rai Medical College Meerut
Uttar Pradesh pin 250004
India
|
|
|
Primary Sponsor
|
| Name |
Lala Lajpat Rai Medical College, Meerut, U.P. |
| Address |
Department of Anaesthesia, Lala Lajpat Rai Medical College, Meerut, U.P. |
| 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 Vipin Kumar dhama |
LLRM Medical college |
Department of anaesthesiology
LLRM Medical College Meerut
Uttar Pradesh 250004
India
Meerut
UTTAR PRADESH |
9760014177
Drvipindhama@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade l and grade ll in adult patients undergoing elective surgery |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insertion of AMBU AURA 40 |
AMBU AURA-40 is consist of an oral inflatable cuff at patient end which is molded to the shaft to form a single unit for providing extra safety.The shaft has built in anatomically correct curve for easy insertion and the tip of cuff is reinforced to resist folding over during insertion h plugs the upper oesophageal Sphincter . The device is ergonomically shaped for firm grip during insertion and has convenient depth mark to confirm the position after insertion. It is made of silicone and can be reused after sterilization after 40 times. |
| Comparator Agent |
Insertion of Baska Mask |
BASKA MASK has a high seal pressure gastric access port and
wide block which facilitate ventilation, provide airway protection and minimize
airway Obstruction. It is oval shaped anatomically Curved airway tube which
incorporates gastric drain tube and a gel like cuff.
The baska mask presents with a bite block throughout the entire length of the
airway tube. The oval shaped airway tube matches the shape of mouth and
reduces rotation within the pharynx. |
| Intervention |
Insertion of supraglottic airway devices |
Comparison of various
parameters like heamodynamic
changes,number of attempts and ease of insertion and complication during insertion and after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist (ASA) grade I and II patients
Age 18-65 years of either gender
Patient scheduled to undergo elective surgical procedures.
Predicted normal airway on PAC |
|
| ExclusionCriteria |
| Details |
patient undergoing any airway surgery
Patient having severe systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare no. of attempts and ease of insestion. |
At the time of device insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes (HR,SPO2,SBP,DBP) which
occurs during Ambu Aura 40 and Buska mask airway during
insertion |
Base line,every 5 minutes, then 10 minutes
and then every 15 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/08/2024 |
| 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 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 prospective randomised comparative evaluation of Ambu aura 40 &baska mask airway in adult patients undergoing elective surgery. We conducting this study for 2 years.we compared changes in heamodynamic parameters, number of attempts, ease of insertion and other complications. We will conduct this study in patients with minimum comorbidities |