| CTRI Number |
CTRI/2023/03/050386 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficiency and performance of AMBU AURA40 with proseal LMA |
|
Scientific Title of Study
|
A comparative evaluation of performance of AMBU AURA40 with Proseal LMA:A randomised prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
Pt.B.D. Sharma PGIMS rohtak |
| Address |
Department of Anaesthesiology and critical care
Pt.B.D.Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiranpreet Kaur |
| Designation |
Professor |
| Affiliation |
Pt.B.D. Sharma PGIMS rohtak |
| Address |
Department of Anaesthesiology and critical care
Pt.B.D.Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9992249436 |
| Fax |
|
| Email |
kiranpreet72@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Miraarabinth |
| Designation |
Junior resident |
| Affiliation |
Pt. B.D.Sharma PGIMS rohtak |
| Address |
Department of Anaesthesiology and critical care,
Pandit B.D. Sharma PGIMS rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9677393710 |
| Fax |
|
| Email |
miraarabinth1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional
Pt.B.D.sharma PGIMS rohtak |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical care |
| Address |
Pt. B.D.Sharma PGIMS rohtak |
| 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 Miraarabinth |
Pandit B.D Sharma PGIMS rohtak |
Department of Anaesthesiology and Critical care
PGIMS rohtak
Rohtak
HARYANA |
9677393710
miraarabinth1997@gmail.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 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMBU AURA40 |
Standardized anaesthesia protocol will be followed. Peripheral intravenous line will be secured with appropriate sized cannula. Pre-oxygenation for 3 minutes will be done with 100% oxygen. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1), fentanyl (2µkg-1) and propofol (2.5mgkg-1). After achieving adequacy of ventilation, neuromuscular blockade will be achieved with vecuronium (0.1mgkg-1). Patient will be ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen and 2% isoflurane. An appropriate size of Ambu Aura40 will be selected as per manufacturer’s recommendation according to weight. Airway device will be checked before use as recommended and will be lubricated with water based gel. Airway devices will be introduced using the standard technique for insertion. Correct placement of the device will be confirmed by chest auscultation, and display of a square wave capnography trace. In event of difficult ventilation following insertion of device, airway device will be repositioned or reinserted. If difficulty in placement is observed, then manoeuvres recommended by manufacturer will be used for respective device. A maximum of three attempts will be taken. If still placement problem is encountered, it will be considered failure.
|
| Comparator Agent |
Proseal LMA |
Standardized anaesthesia protocol will be followed. Peripheral intravenous line will be secured with appropriate sized cannula. Pre-oxygenation for 3 minutes will be done with 100% oxygen. Induction of anaesthesia will be done with glycopyrrolate (0.005mgkg-1), fentanyl (2µkg-1) and propofol (2.5mgkg-1). After achieving adequacy of ventilation, neuromuscular blockade will be achieved with vecuronium (0.1mgkg-1). Patient will be ventilated for 3 minutes via facemask and anaesthesia breathing system with 100% oxygen and 2% isoflurane. An appropriate size of Proseal LMA (size 3 or 4) will be selected as per manufacturer’s recommendation according to weight. Airway device will be checked before use as recommended and will be lubricated with water based gel. Airway devices will be introduced using the standard technique for insertion. Correct placement of the device will be confirmed by chest auscultation, and display of a square wave capnography trace. In event of difficult ventilation following insertion of device, airway device will be repositioned or reinserted. If difficulty in placement is observed, then manoeuvres recommended by manufacturer will be used for respective device. A maximum of three attempts will be taken. If still placement problem is encountered, it will be considered failure.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-60 years of either sex of ASA grade I and II scheduled for elective surgery requiring general anaesthesia and where placement of supraglottic airway device is indicated will be included.
|
|
| ExclusionCriteria |
| Details |
Patients having respiratory or pharyngeal pathology, mouth opening <2.5 cms, Body mass index > 30 kg/m², pregnancy, full stomach, suspected difficult airway will be excluded.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the success rate of placement and OLP for the two devices
|
Insertion time and number of attempts taken for placing the device noted.Hemodynamic changes assessed baseline,after induction,after insertion and 5 min after device placement.post op complications-immediate,after half an hour and after 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for placement
Number of attempts
Haemodynamic variation
Post-operative complications |
Hemodynamic changes assessed baseline,after induction,after insertion and 5 min after device placement.post op complications-immediate,after half an hour and after 1 hour will be assessed for both AMBU AURA40 and Proseal LMA. Data will be compiled and appropriate statistical tests will be used to analyse the results |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2023 |
| Date of Study Completion (India) |
07/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [miraarabinth1997@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 31-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
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Brief Summary
|
Supraglottic devices play an important role in airway management.The increased use of LMA in anaesthesia practice is because of the ease of use,safety and smooth recovery.In this study we are comparing the performance between Ambu Aura40 and proseal LMA which are supraglottic airway devices.Though Proseal LMA and variants of Ambu Aura have been previously compared,there is no earlier studies in literature comparing the clinical performance of proseal LMA and Ambu Aura40.The present study is intended to compare the ease of insertion, success rate and oropharyngeal leak pressure between proseal LMA and ambu Aura40 |