| CTRI Number |
CTRI/2022/08/044742 [Registered on: 18/08/2022] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of performance of Ambu Aura Gain and I gel in fatty female patients undergoing short duration surgeries under general anaesthesia |
|
Scientific Title of Study
|
Clinical performance evaluation of Ambu- Aura Gain versus I-gel in Obese female patients undergoing Short duration Surgeries under general anesthesia (CAAIOSS): a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suparna Mitra Barman |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, critical care and pain, E-W,Major Arterial Road, New Town, Kolkata-700160 Department of Anaesthesia, critical care and pain,14 E-W,Major Arterial Road, New Town, Kolkata-700160 North Twentyfour Parganas WEST BENGAL 700160 India |
| Phone |
|
| Fax |
|
| Email |
suparna.barman@tmckolkata.com |
|
Details of Contact Person Scientific Query
|
| Name |
Suparna Mitra Barman |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160 Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160 North Twentyfour Parganas WEST BENGAL 700160 India |
| Phone |
|
| Fax |
|
| Email |
suparna.barman@tmckolkata.com |
|
Details of Contact Person Public Query
|
| Name |
Suparna Mitra Barman |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, critical care and pain, 14 E-W,Major Arterial Road, New Town, Kolkata-700160 Department of Anaesthesia, critical care and pain,14 E-W,Major Arterial Road, New Town, Kolkata-700160 North Twentyfour Parganas WEST BENGAL 700160 India |
| Phone |
|
| Fax |
|
| Email |
suparna.barman@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, Kolkata |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [nil] |
|
|
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 Suparna Mitra Barman |
Tata Medical Center |
Operation theatre, Department of Anaesthesia, critical care and pain, 14 MAR (E-W), New Town, Pin-700160 North Twentyfour Parganas WEST BENGAL |
8017552743
suparna.barman@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ambu-Aura Gain |
Oro pharyngeal leak pressure (OLP) at 1 minute after insertion of Ambu-Aura Gain |
| Comparator Agent |
I-gel |
Oro-pharyngeal leak pressure (OLP) at 1 minute after insertion of I-gel |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Duration of surgery less than 3 hours
2. American society of anesthesiologists class(ASA) 1,2,3
3. Body mass Index more than 30kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Emergency surgery
2. ASA more than 3
3. History of Cervical spine disorder or surgery
4. Risk of aspiration
5. Anticipated difficult airway
Surgery requiring pneumo-peritoneum,
trendelenburg, lateral or prone positioning, surgery in head and neck region or involving the airway |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OLP after insertion of SAD |
OLP after insertion of SAD at 1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. OLP after insertion of SAD
2. Time of insertion
3. No of insertion attempts
4. Ease of insertion
5. Additional airway maneuvers during insertion and maintenance
6. Fibreoptic bronchoscopic view
7. Ease of suction catheter placement
8. Ventilation quality
9. Complications
|
at 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="8" 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 - NO
|
|
Brief Summary
|
Supraglottic airway devices (SAD) have been used to secure and maintain airways in patients during surgery or emergency situations, as well as in the management of expected and unexpected difficult airways. I-gel is a second-generation SAD which has a soft non-inflatable cuff and a gastric access port, has been widely used in patients undergoing surgery under general anesthesia. A third-generation SAD, Ambu Aura Gain, has an inflatable cuff and a gastric port. One of the key features of the Ambu Aura Gain is the 90-degree angulated shaft, following the anatomy of the upper airway, which facilitates proper insertion and is associated with a high success rate for insertion. To compare the clinical performance of Ambu Aura Gain versus I-gel in patients undergoing breast surgery under general anesthesia. Patients who will undergo elective breast surgery will be randomized either to the Ambu Aura Gain group (group A) or the Igel group (Group B) (Sample size of 40 in each group). In both the groups, general anesthesia will be administered. For patients allocated to Group A, airway will be secured with Ambu Aura Gain of appropriate size (as per manufacturer’s recommendation). For patients allocated to Group B, airway will be secured with I-gel of appropriate size (as per manufacturer’s recommendation). Primary outcome to be observed will be oropharyngeal leak pressure (OLP) at 1 minute after insertion. Secondary outcome to be observed are: oropharyngeal leak pressure (OLP) at 30 minute after insertion, time and ease of insertion of SAD, no of insertion attempts, additional airway maneuvers during insertion and maintenance, fibreoptic bronchoscopic view score, ease of suction catheter placement, ventilation quality, complications. All statistical analyses will be performed using the Statistical Package for the Social Sciences software, v22.0 (SPSS Inc., Chicago, IL, USA).
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