| CTRI Number |
CTRI/2024/11/076666 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of different modes of ventilation with AMBU AURAGAIN laryngeal mask airway and its influence on gastric volume |
|
Scientific Title of Study
|
Comparison of different modes of ventilation with AMBU AURAGAIN laryngeal mask airway and its influence on gastric volume : An observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siri Kandavar |
| Designation |
Associate professor |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy Hospital
Nithyananda nagar
Deralakatte
Mangaluru , Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
-575018
India |
| Phone |
918242204490 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siri Kandavar |
| Designation |
Associate professor |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy Hospital
Nithyananda nagar
Deralakatte
Mangaluru , Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
-575018
India |
| Phone |
918242204490 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siri Kandavar |
| Designation |
Associate professor |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesiology
K S Hegde Medical Academy Hospital
Nithyananda nagar
Deralakatte
Mangaluru , Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
-575018
India |
| Phone |
918242204490 |
| Fax |
|
| Email |
sirikandavar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.S Hegde Medical Academy
Deralakatte, Mangalore 575018, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Bhanu Prasanna K |
| Address |
Dr Bhanu Prasanna K
K.S Hegde medical Academy Deralakatte,Mangalore 575018 Karnataka India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| BHANU PRASANNA K |
K.S Hegde Medical Academy |
Department of Anaesthesiology
K.S Hegde Medical Academy
Deralakatte,Mangalore 575018
Karnataka India
Dakshina Kannada
KARNATAKA |
8374299328
bhanuprasu25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Measuring gastric volume with different modes of ventilation with ambu auragain |
Evaluating gastric volume in ambu auragain supraglottic airway device with PCV mode and VCV mode ventilation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status I and II
Elective surgeries with supraglottic airway device |
|
| ExclusionCriteria |
| Details |
Congenital facial anomalies
Gastroesophageal reflex disease
COPD
Asthma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure change in gastric volume with different modes of ventilation |
From facemask ventilation upto post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Confirm position of the supraglottic airway device
To measure peak inspiratory pressure in VCV mode
To measure oropharyngeal seal pressure
To study post operative complications |
Confirming position post intubation
Measuring peak pressure post intubation
Measuring seal pressure post intubation
Post operative complications after shifting to post operative ward |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
17/11/2024 |
| 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 Applicable |
| 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
|
This study involves evaluating gastric volume in ambu auragain in VCV and PCV mode of ventilation. Gastric insufflation can cause risks such as aspiration and can obscure the surgical field.This study aims to reduce these risks by reducing the gastric insufflation when present. |