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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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  
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