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CTRI Number  CTRI/2024/03/063929 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Fasting gastric volume comparison between diabetic and non-diabetic preoperative patients 
Scientific Title of Study   Preoperative Ultrasonographic Comparison of Fasting Gastric Volume In Diabetic & Non-Diabetic Patients. Prospective Analytical 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  Eldho Joy 
Designation  Junior Resident  
Affiliation  Goa Medical College 
Address  Goa Medical College, Bambolim, Goa
Department of Anaesthesiology, Goa Medical College, Bambolim, 403202
North Goa
GOA
403202
India 
Phone  8552837062  
Fax    
Email  eldho.manavalan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shirley Ann Dsouza 
Designation  Professor and HOD 
Affiliation  Goa Medical College 
Address  Department of Anaesthesiology, Goa Medical College, Bambolim

North Goa
GOA
403202
India 
Phone  9822159170  
Fax    
Email  shirley_dsouza05@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Shirley Ann Dsouza 
Designation  Professor and HOD 
Affiliation  Goa Medical College 
Address  Department of Anaesthesiology, Goa Medical College, Bambolim

North Goa
GOA
403202
India 
Phone  9822159170  
Fax    
Email  shirley_dsouza05@yahoo.com  
 
Source of Monetary or Material Support  
Goa Medical College 
 
Primary Sponsor  
Name  Goa Medical College 
Address  Goa Medical College , Bambolim, Goa, 403202 
Type of Sponsor  Government 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 
Eldho Joy  Goa Medical College  Pre Operative Waiting Area of Operation Theatre ,Department Of Anesthesiology
North Goa
GOA 
8552837062

eldho.manavalan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients scheduled for surgery with preoperative fasting period of 8-10 hours
ASA physical status: I, II and III
Body mass index <30kg/m2

 
 
ExclusionCriteria 
Details  Pregnant patient
Gastroesophageal reflux disease
Recent abdominal trauma and previous gastrointestinal surgery
Patients who are unable to turn & lie in right lateral position
Patients with nasogastric tube in situ
conditions and drugs that alter gastric emptying
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine and compare
the residual gastric volume in preoperative
diabetic and non-diabetic patients 
preoperative fasting period of 8-10 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study the fasting gastric
volume in relation to
1.Control of diabetes in terms of HbA1c & duration of diabetes  
preoperative fasting period of 8-10 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Preoperative Ultrasonographic Comparison of Fasting

Gastric Volume In Diabetic &  Non-Diabetic Patients :

Prospective Analytical Observational Study

 

Candidate: Dr Eldho Joy

Junior resident

Department of Anaesthesiology

Goa Medical College , Bambolim ,Goa

 

Guide: Dr Shirley Ann D’Souza

Professor and HOD

Department of Anaesthesiology

Goa Medical College , Bambolim ,Goa

 

Introduction

• Point of care gastric ultrasonography is a simple,

readily available, non invasive & easy to perform

diagnostic tool to examine the volume of gastric

content and determine pulmonary aspiration risk

• Data on fasting gastric content and volume in

preoperative patients with Diabetes Mellitus is

limited and contradictory . Hence the present

study

 

Aim & Objectives

 

• Research Question: Whether the gastric volume is

more than the safe limit in diabetic as compared

to non - diabetic patients despite adequate

fasting?

• Primary objective – To determine and compare

the residual gastric volume in preoperative

diabetic and non-diabetic patients.

• Secondary objective –To study the fasting gastric

volume in relation to

1.Control of diabetes in terms of HbA1c &amp;

2. Duration of diabetes.

 

Materials and Methods

• Study design – Prospective, Analytical

Observational study

• Study Setting – Preoperative Area Of Operation

Theatre in Goa Medical College

• Study Duration – March 2024 - March 2025

• Sampling Method – Universal Sampling

• Sample Size – Total 80 (40 Diabetic & 40 Non-

Diabetic)

 

 

 

n = sample size

 

All statistical calculation will be done using SPSS

software .

 

Inclusion Criteria

 

• Patients scheduled for elective surgery with

preoperative fasting period of 8-10 hours

• Age: 18-65 years

• Sex: Either sex

• ASA physical status: I, II

• Body mass index < 30kg/m 2

 

Exclusion Criteria

 

• Pregnant patient

• Gastroesophageal reflux disease

• Recent abdominal trauma/ previous

gastrointestinal surgery

• Patients who are unable to turn & lie in right

lateral position

• Patients with nasogastric tube in situ

• Conditions/ drugs that alter gastric emptying

 

Procedure

 

Patients will be divided into 2 groups based on

diagnosis of Diabetes Mellitus

Group A (Diabetic)

Group B (Non Diabetic)

• Ultrasonography in preoperative waiting area will

be done with

• A portable ultrasound machine with curved array

low frequency (2-5MHz) probe.

• The epigastrium will be scanned in sagittal plane in

Supine position followed by Right Lateral

Decubitus (RLD) position.

 

The gastric antrum is identified just below the left lobe

of liver and pancreas where the aorta and inferior vena

cava serve as important vascular landmark.

The sonographic appearance of gastric antrum is

classified as

Grade 1-empty antrum

Grade 2-fluid detected in right lateral position only

Grade 3-antral fluid in both supine and right lateral

position

 

Empty Antrum - Bulls-eye’ appearance

Thick muscularis propria layer

Clear fluid - Hypoechoic ,distended antrum

Gastric antrum

(A) containing fluid with some air bubbles

(B) containing fluid with ‘starry night’ appearance

Solids- distended antrum

(C) After recent ingestion of solids, with a ‘frosted

glass’ appearance.

(D) Gastric antrum containing solids, in later stage

shows hyperechoic heterogeneous consistency

representing different consistency of solids consumed

 

Quantitative Assessment

 

• Cross-sectional area (CSA) is calculated by using

two perpendicular diameters :

Antero-Posterior(AP) &amp; Cranio-Caudal (CC) &amp;

the formula CSA=( AP x CC x Ï€ ) /4

Perlas formula

Gastric residual volume(ml) =

27.0+ 14.6 x right lateral CSA – 1.28 x age

 

PATIENTS INFORMATION SHEET

 

Title - Preoperative Ultrasonographic Comparison of Fasting Gastric Volume In Diabetic &amp; Non-

Diabetic Patients.

Introduction – We would like to invite you to participate in the research project . Before you

decide you need to understand why the research is being done and what will it involve for you.

Please read this information sheet carefully and ask questions about anything you do not

understand .You can also talk to others before you decide.

Purpose of the study- To determine and compare the residual gastric volume in preoperative

diabetic and non-diabetic patients.

Whether the gastric volume is more than the safe limit in diabetic as compared to non - diabetic

patients despite adequate fasting.

Risks to you- no risk.

Benefits to you- Based on the results of the study , we will be able to examine stomach contents

and determine pulmonary aspiration risk by a non invasive way.

.Participating in the study will not provide you any financial or medical benefit.

Confidentiality-

All data collected will be kept confidential.

Do I have to take part ? - You will be included in the study only after voluntary consent.

Your right to withdraw-

Its not compulsory that you have to participate in the study .Even after your consent for the study

,you are free to withdraw from it at any given point of time.

If you have any problems or questions regarding the study ,please feel free to contact any of the

investigator whose details are given below .

Problems or Questions -

You will be given a copy of this form .If you have any problems or questions regarding the study

,please feel free to contact any of the investigator whose details are given below . You will be asked

to provide your contact details so that the study organizers can contact you.

Investigators details – Dr Eldho Joy, Junior Resident.

Phone number- 8552837062

Address- GARD Hostel , Goa medical college, Bambolim, Goa .

In case of any ethical issue please contact- Member Secretary, Institutional Ethical Committee, Goa

Medical College, Goa.

 

CONSENT FORM FOR PARTICIPANTS

 

I             ,confirm that I have read and understood the participants information sheet

for the above study titled as ‘Preoperative Ultrasonographic Comparison of

Fasting Gastric Volume In Diabetic & Non-Diabetic Patients ‘.

I am aware that my participation in this study is voluntary and I have the right to withdraw

from this study at any point of time without stating my reasons for it and without my right

being affected.

I understand that all information collected from me will be kept strictly confidential and no

information will be given to anyone including institutional authorities, apart from the study

investigators.

I understand that this study will involve :

Collection of my personal and clinical details.

Collection of investigational reports.

I understand that the information I provide will be used only to fulfill the above stated

objective and will not be used in any way that is harmful or discriminatory against me.

I agree that the data or the results that arise from the study can be used for a scientific

purpose . I understand that there are no monetary benefits to me from this study.

Signature of the participant / custodian-

Name of the participant / custodian-

Signature of witness –

Signature of the Investigator-

Name and details of investigator –

Contact number of investigator-

Date-

 

Time-

 

PROFORMA

 

Hospital registration number:

Date

 

                                                         DIABETIC                                   NON DIABETIC

 

Age

Sex

ASA –PS

Weight

Height

BMI

Years since

diagnosis of DM

Medication

Insulin

OHA

Insulin & OHA

HbA1c

Creatinine

DM neuropathy

Hours of fasting

solid

Liquid

 

USG

Grade 1

Grade 2

Grade 3

 

Antero-

Posterior(AP)

Diameter

(Right Lateral)

 

Cranio-Caudal (CC)

Diameter

 

CSA=

 

Gastric residual

volume(ml) =

27.0+ 14.6 x right

lateral CSA – 1.28 x

age

 

REFERENCES

 

1. CubillosJ, Tse C, Chan VW, PerlasA. Bedside ultrasound

assessment of gastric content:An observational study.

Can JAnaesth 2012;59:416–23.

2. Van de Putte P, Perlas A. Ultrasound assessment of

gastric content and volume. Br J Anaesth

2014;113:1222.

3. Krishnasamy S,Abell TL. Diabetic gastroparesis:

Principles and current trends in management. Diabetes

Ther 2018;9:1–42.

4. Garg H, Podder S, Bala I, GulatiA. Comparison of fasting

gastric volume using ultrasound in diabetic and

nondiabetic patientsin elective surgery: An

observational study. Indian J Anaesth 2020;64:3916.

5. Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L,

et al. Validation of a mathematical model for ultrasound

assessment of gastric volume by gastroscopic

examination. Anesth Analg 2013;116:35763.

6. Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS,

Helmy N. Evaluation of gastric residual volume in fasting

diabetic patients using gastric ultrasound. Acta

Anaesthesiol Scand 2019;63:6159.

7. Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli

E, Benhamou D. Clinical assessment of the

ultrasonographic measurement of antral area for

estimating preoperative gastric content and volume.

Anesthesiology 2011;114:108692.


 
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