| CTRI Number |
CTRI/2024/02/062470 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Ultrasound at the Bedside to Estimate Stomach Size and Check for Food or Drink in the Stomach in Adults Before Planned Surgery under General Anesthesia- A Prospective Observational Study |
|
Scientific Title of Study
|
Estimation of Gastric Volume and Presence of Gastric Contents using Bed Side Ultrasonography in Adults Undergoing Elective Surgery Under General Anaesthesia - A Prospective 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 |
Haritha V R |
| Designation |
DNB Resident in Anaesthesiology |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Anaesthesiology and Critical care
Sakra World Hospital
Bangalore
Karnataka
560103
India
Bangalore
KARNATAKA
560103
India |
| Phone |
9495995162 |
| Fax |
|
| Email |
harithavr1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaijayanthi Sharma |
| Designation |
Consultant in Anaesthesiology |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Anesthesiology & Critical Care
Sakra World Hospital
Bangalore
Karnataka
560103
Bangalore
KARNATAKA
560103
India |
| Phone |
9741978947 |
| Fax |
|
| Email |
vaijusharma81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Haritha V R |
| Designation |
DNB Resident in Anaesthesiology |
| Affiliation |
Sakra World Hospital |
| Address |
Department of Anaesthesiology and Critical care
Sakra World Hospital
Bangalore
Karnataka
560103
India
Bangalore
KARNATAKA
560103
India |
| Phone |
9495995162 |
| Fax |
|
| Email |
harithavr1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sakra World Hospital
Bangalore
|
|
|
Primary Sponsor
|
| Name |
Haritha V R |
| Address |
Department of Anaesthesiology
Sakra World Hospital
Bangalore |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Haritha V R |
Sakra World Hospital |
Deparment of Anaesthesiology
Sakra World Hospital
Bangalore
Bangalore
KARNATAKA |
9495995162
harithavr1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sakra Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients undergoing elective surgery under general anaesthesia
2)Patients with pre operative fasting of at least 6 hours for solid food ,2 hours for clear liquids as per ASA fasting guidelines |
|
| ExclusionCriteria |
| Details |
1)Patients who refuse to provide informed consent
2)Emergency Surgeries with rapid sequence induction
3)Pregnant women
4)Age group less than 18 years
5)Previous surgery of upper gastrointestinal tract
6)Patients unable to turn and lie in right lateral position |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative and Qualitative assessment of gastric contents in adults following standard fasting guidelines prior to elective surgery using bedtime ultrasonography |
Baseline is gastric volume assessment in supine position followed by volume assessment in right lateral decubitus position immediately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the influence of factors like age, body weight & other comorbidities in determination of gastric volume prior to surgery & to find out the risk of preoperative aspiration |
My study is the assessment of gastric volume & presence of gastric contents in two different postions. supine & right lateral decubitus positions in pre operative area There is no specific time points related to study |
|
|
Target Sample Size
|
Total Sample Size="143"
Sample Size from India="143"
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)
|
12/02/2024 |
| 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="1"
Months="6"
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 is a prospective ,observational study for estimating gastric volume and presence of gastric contents in adults following standard fasting guidelines prior to surgery ,using bedside ultrasonography. Measurement of gastric antrum is done both in supine and right lateral decubitus position in pre operative room .Based on this study ultrasound can be used as a standard of care in such patients to prevent the risk of pulmonary aspiration. |