| CTRI Number |
CTRI/2018/12/016750 [Registered on: 20/12/2018] Trial Registered Prospectively |
| Last Modified On: |
19/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
time taken for stomach to get empty afterfull meal in healthy male volunteer using ultrasound |
|
Scientific Title of Study
|
Ultrasound guided assessment of gastric emptying time in healthy volunteers following a full standardised meal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drdarshanshetty |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anaesthesiology, KMC Manipal,udupi district, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9738756924 |
| Fax |
|
| Email |
Dr.darshanshetty91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin udupa |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college |
| Address |
department of anesthesiology,kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861926929 |
| Fax |
|
| Email |
aswinudupa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr manjunath prabhu |
| Designation |
proffesor |
| Affiliation |
Kasturba medical college |
| Address |
Department of Anaesthesiology, KMC Manipal,udupi district, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9738756924 |
| Fax |
|
| Email |
manja.parkala@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of higher education, Kasturba medical college and hospital, Manipal , udupi,Karnataka. |
|
|
Primary Sponsor
|
| Name |
PG THESIS FUND KMC MANIPAL |
| Address |
Kasturba medical college and hospital, Manipal, Udupi district, Karnataka - 576104 |
| Type of Sponsor |
Private 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 |
| darshan shetty |
Kasturba hospital |
department of anaesthesiology
KMC manipal
Kasturba hospital
Udupi
Udupi
KARNATAKA |
9738756924
dr.darshanshetty91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gastric volume |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
ultrasonography |
healthy volunteer is made supine and ultrasound probe kept on his abdomen and the scan of gastric contents and volume done.the ultrasound scan is done every hour for 6 hours or until baseline gastric volume is achieved |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
healthy volunteers
no comorbidities
ASA1
male volunteers
fasting for 6 hours |
|
| ExclusionCriteria |
| Details |
volunteers with poor visualization of gastric antrum under ultrasonography
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gastric volume and gastric emptying time |
every hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gastric volume and risk of aspiration |
every hour |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/12/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To assess gastric emptying time after a full standardized meal,under ultrasound guidance. by keeping healthy male volunteers nil per oral for 6 hours and measuring the baseline gastric volume when empty, then after a standardized meal to measure reduction in gastric volume until it reaches baseline or upto 6 hours |