Relation between diabetic hemoglobin and area of the stomach seen with ultrasound before surgery in diabetic patients who are fasting for routine surgery
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/11/038029
- Lead Sponsor
- AIIMS BHUBANESWAR
- Brief Summary
INTRODUCTION
Diabetic patients are prone to have gastroparesis with increased gastric content (1,2). Full stomach is well known risk factor for aspiration in the perioperative period and development of post-operative pulmonary complications (3). Patients with poorly controlled diabetes are known to have more diabetes related complications. HbA1c is a marker for glycemic control over the last 3 months and reflects euglycemia or dysglycemia (4). Poorly controlled diabetes having more than normal HbA1c levels will have a higher preoperative gastric content even after following fasting guidelines (5,6,7).
Gastric antral cross-sectional area measured by ultrasound (USG) is a good parameter to establish the gastric volume in preoperative patients (8-11). Hence, we hypothesize that there will be a significant positive correlation between preoperative HbA1c and gastric antral cross-sectional area.
STUDY OBJECTIVES
Primary objective: To establish a correlation between preoperative HbA1c and gastric antral cross- sectional area (CSA) in fasting diabetics undergoing elective surgery
Secondary objectives:
l)To determine the cutoffHbAlc value that signifies ’high risk stomach’ defined as gastric antral cross -sectional area (CSA) more than 340 mm2(15).
2)To find a correlation between mean HbA1c and Perlas grading (14).
3)To evaluate the effect of age and years of diabetes.
REVIEW OF LITERATURE
Search Strategy:
For the purpose of literature search, a baseline knowledge regarding the procedures was gained by referring to the standard textbooks on diabetes mellitus and anaesthesiology. Further, focused search was carried out in the MEDLINE database using PubMed search engine, Google Scholar search engine, Ovid Medline, EMBASE and Cochrane library using the following key-words: diabetes mellitus, gastric ultrasound, aspiration in perioperative period.
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Review: During perioperative period, aspiration of gastric contents is a dreaded complication. It can lead to considerable morbidity such as prolonged mechanical ventilation; ICU stay and has a risk of mortality up to 5% (11). Aspiration is the cited reason in up to 9% of anaesthesia-related deaths (12, 13). Diabetics are known to have a greater incidence of autonomic dysfunction. This can lead to gastroparesis and result in delayed gastric emptying which makes them more susceptible to aspiration than the general population (1,2). Izzy M et al. (6) have showed that a correlation exists between the HbA1c level and the severity of gastroparesis.
Ultrasound (USG) is commonly available and has been proven to be an authentic bedside assessment device for real-time evaluation of gastric contents (7-10). Antral CSA serves as a proxy marker of gastric fluid volume (7-10). Darwiche G et al. (2) have demonstrated that serial antral CSA measurements correlate well with scintigraphic evaluation of gastric emptying time. Perlas A et al. have a given the description of a grading system for the sonographic gastric antral CSA (14).
Garg H et al. (5) have concluded that fasting diabetics have a higher gastric residual volume than non-diabetics undergoing surgery. In this study, we intend to find a correlation between the pre — operative HbA1c and gastric CSA.
METHODOLOGY:
Study Design and Setting: The study will be a prospective, observational cross-sectional study among diabetic adults undergoing elective surgeries who have given a valid informed consent for the study in AIIMS, Bhubaneswar.
Inclusion criteria: Adults with diabetes undergoing elective surgeries
Exclusion criteria:
1. Refusal to participate
2. Previous history of gastric surgeries
3. Any other condition associated with gastroparesis (renal failure, liver disease, GERD, pregnant women, BMI > 30kg/m2, drugs that affect gastric motility like anti- cholinergic, opioids, prokinetics, GLP-I analogues, amylin analogues)
Sample Size: Purposive sampling: July 2021- December 2022.
PROCEDURE:
Preoperative HbA1c is a routinely done investigation in all diabetic patients undergoing surgery for the purpose of prognostication. Standard fasting guidelines will be followed in all. Written consent will be obtained after explaining the procedure to the patients.
Ultrasound will be done in the preoperative area on the morning of surgery.
Gastric ultrasound: A low-frequency (2-5MHz) curved ultrasound probe will be used. The stomach will be seen in the epigastric area in a sagittal plane, just below the xiphoid process and above the umbilicus. The transducer will be moved from left to right subcostal margin to find the suitable sonoanatomy.
The antrum can be seen as a hollow viscus in the superficial plane with a thick multi-layered wall just below the left lobe of the liver and anterior to the body of pancreas. Posterior to the antrum, inferior vena cava and the aorta will be visualized. The craniocaudal
(CC) and the antero-posterior (AP) will be measured at the level where the aorta is visualized.
Superior mesenteric artery or vein can sometimes be seen next the antrum
This will be done in two patient positions — supine and then right lateral decubitus position.
Assessment of gastric antral CSA:
Anteroposterior (AP) and Craniocaudal (CC) diameters will be measured serosa-toserosa in between peristaltic contractions, if present. The gastric antral CSA will be then calculated using the following formula (9):
Gastric antral CSATT x craniocaudal diameter (CC) x anteroposteriordiameter (AP) 4
Gastric antral CSA more than 340mm is considered significant, i.e., high risk stomach.
Grading of gastric USG:
Grade 0 - empty in both right lateral and supine position
Grade I mildly distended antrum in right lateral decubitus, but not in supine position
Grade 2 - antrum is distended in both supine and right lateral decubitus position with fluids or presence of solids in any position
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|FIG 1: Gastric USG done in supine followed by right lateral position.
FIG 2: Measurement of the anteroposterior (AP) and craniocaudal (CC)diameters.
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|FIG 3: GRADE O
empty antrum
FIG 4: GRADE 1 - Fluid in the right lateral decubitus position.
FIG 5: GRADE 2- Fluid in supine and right lateral decubitus position
STUDY ANALYSIS
All the data will be recorded in the master chart. Observational analysis will be performed on the study results and it will be analysed statistically using SPSS software. Continuous data will be expressed in terms of mean ± SD. Categorical data will be expressed as proportions. Discrete variables will be analysed using Chi-square or Fisher’s test. And t-test will be used for parametric data. P value < 0.05 will be considered statistically significant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Adults with diabetes undergoing elective surgeries.
a)Refusal to participate b)Previous history of gastric surgeries c)Any other conditions with gastroparesis (renal failure,liver failure,GERD,pregnant women,BMI > 30kg/m2,,drugs that affect gastric motility like anti-cholinergc,opiods,prokitics, GLP-1analogues,amylin analogues).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between preoperative HbA1c and gastric antral cross sectional area (CSA) Single time point - immediately before surgery once
- Secondary Outcome Measures
Name Time Method 1)Cut-off value that signifies high-risk stomach defined as gastric antral cross sectional area more than 340 square millimeter 2)To find a correlation between mean HbA1c and Perlas grading of gastric antral cross sectional area
Trial Locations
- Locations (1)
AIIMS BHUBANESWAR
🇮🇳Khordha, ORISSA, India
AIIMS BHUBANESWAR🇮🇳Khordha, ORISSA, IndiaDR SHWETA DESAIPrincipal investigator6361883993shwetadesai991@gmail.com