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 |