| CTRI Number |
CTRI/2023/03/050625 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the gastric volume in diabetic and non diabetic patients posted for elective surgeries using ultrasound |
|
Scientific Title of Study
|
Evaluation of gastric residual volume
using ultrasound in fasting diabetic
patients and non diabetic patients
scheduled for elective surgeries; A
Comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TJyothi Swaroop |
| Designation |
junior resident |
| Affiliation |
SHRI B.M.Patil medical college,hospital and research center |
| Address |
BLDE Medical college and hospital,bangaramma sajjan campus,sholapur road,vijaypura,karnataka.
Bijapur
KARNATAKA
586103
India |
| Phone |
9916243462 |
| Fax |
|
| Email |
swaroop0603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridevi Mulimani |
| Designation |
professor |
| Affiliation |
SHRI B.M.Patil medical college,hospital and research center |
| Address |
BLDE Medical college and hospital,bangaramma sajjan campus,sholapur road,vijaypura,karnataka.
Bijapur
KARNATAKA
586103
India |
| Phone |
9449534216 |
| Fax |
|
| Email |
sridevi.mulimani@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sridevi Mulimani |
| Designation |
professor |
| Affiliation |
SHRI B.M.Patil medical college,hospital and research center |
| Address |
BLDE Medical college and hospital,bangaramma sajjan campus,sholapur road,vijaypura,karnataka.
Bijapur
KARNATAKA
586103
India |
| Phone |
9449534216 |
| Fax |
|
| Email |
sridevi.mulimani@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Shri BM Patil medical college, hospital and research center
|
|
|
Primary Sponsor
|
| Name |
SHRI B.M.Patil medical college,hospital and research center |
| Address |
BLDE Medical college and hospital,bangaramma sajjan campus,sholapur road,vijaypura,karnataka |
| 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 |
| jyothi swaroop |
Shri B M Patil medical college |
Department of Anaesthesiology,bangaramma sajjan campus,BLDE University,vijaypura.
Bijapur
KARNATAKA |
9916243462
swaroop0603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil medical college and hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted for elective surgeries with ASA Grade I,II,III. |
|
| ExclusionCriteria |
| Details |
Pregnant women.
Obese patients.
Coexisting autoimmune diseases.
Patients with h/o gastric surgeries.
Patients were unable to position in right lateral decubitus position. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric emptying time reduction by fasting to prevent risk of aspiration |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measuring gastric residual volume with respect to duration of diabetes, blood sugar level, HbA1C |
30 minutes before the procedure |
|
|
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)
|
15/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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)?
Response - NO
|
|
Brief Summary
|
My study is to measure the gastric residual volume by comparing the fasting diabetic and non-diabetic patients to conclude the fasting duration to prevent the risk of aspiration in the patients posted for elective surgeries using ultrasound which is a noninvasive method and economical by measuring the cross-sectional area of the antrum |