Fasting gastric volume comparison between diabetic and non-diabetic preoperative patients
- Conditions
- Endocrine, nutritional and metabolic diseases,
- Registration Number
- CTRI/2024/03/063929
- Lead Sponsor
- Goa Medical College
- Brief Summary
PreoperativeUltrasonographic Comparison of Fasting
GastricVolume In Diabetic & Non-DiabeticPatients :
ProspectiveAnalytical 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 &
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 leftlobe
of liver and pancreas where the aorta and inferiorvena
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) & Cranio-Caudal (CC)&
the formula CSA=( AP x CC x π ) /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 ofFasting Gastric Volume In Diabetic & Non-
Diabetic Patients.
Introduction – We would like to invite you toparticipate in the research project . Before you
decide you need to understand why the research isbeing done and what will it involve for you.
Please read this information sheet carefully and askquestions about anything you do not
understand .You can also talk to others before youdecide.
Purpose of the study- To determine and compare theresidual gastric volume in preoperative
diabetic and non-diabetic patients.
Whether the gastric volume is more than the safe limitin 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 invasiveway.
.Participating in the study will not provide you anyfinancial or medical benefit.
Confidentiality-
All data collected will be kept confidential.
Do I have to take part ? - You will be included in thestudy only after voluntary consent.
Your right to withdraw-
Its not compulsory that you have to participate in thestudy .Even after your consent for the study
,you are free to withdraw from it at any given pointof time.
If you have any problems or questions regarding thestudy ,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 anyproblems or questions regarding the study
,please feel free to contact any of the investigatorwhose details are given below . You will be asked
to provide your contact details so that the studyorganizers 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- MemberSecretary, Institutional Ethical Committee, Goa
Medical College, Goa.
CONSENT FORM FOR PARTICIPANTS
I ,confirm that I have read andunderstood the participants information sheet
for the above study titled as ‘PreoperativeUltrasonographic Comparison of
Fasting Gastric Volume In Diabetic & Non-DiabeticPatients ‘.
I am aware that my participation in this study isvoluntary and I have the right to withdraw
from this study at any point of time without statingmy reasons for it and without my right
being affected.
I understand that all information collected from mewill be kept strictly confidential and no
information will be given to anyone includinginstitutional 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 beused only to fulfill the above stated
objective and will not be used in any way that isharmful or discriminatory against me.
I agree that the data or the results that arise fromthe study can be used for a scientific
purpose . I understand that there are no monetarybenefits 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 NONDIABETIC
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. Bedsideultrasound
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 offasting
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 forultrasound
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 infasting
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
Patients scheduled for surgery with preoperative fasting period of 8-10 hours ASA physical status: I, II and III Body mass index <30kg/m2.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the residual gastric volume in preoperative preoperative fasting period of 8-10 hours To determine and compare preoperative fasting period of 8-10 hours diabetic and non-diabetic patients preoperative fasting period of 8-10 hours
- Secondary Outcome Measures
Name Time Method To study the fasting gastric volume in relation to
Trial Locations
- Locations (1)
Goa Medical College
🇮🇳Goa, GOA, India
Goa Medical College🇮🇳Goa, GOA, IndiaEldho JoyPrincipal investigator8552837062eldho.manavalan@gmail.com