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CTRI Number  CTRI/2024/06/068853 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Ultrasound measurement of stomach for residual volume and contents in Diabetic patients undergoing operations– A Prospective Observational Study 
Scientific Title of Study   Ultrasound Assessment Of Gastic Residual Volume and Contents in Diabetic Surgical population – A Prospective 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  Dr Rohan S 
Designation  Post Graduate Student in Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  9740850950  
Fax    
Email  rohansuresh22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohan S 
Designation  Post Graduate Student in Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  9740850950  
Fax    
Email  rohansuresh22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parimala 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Sciences, Cantonment, Ballari.

Bellary
KARNATAKA
583104
India 
Phone  9742530338  
Fax    
Email  dr.parimaladu@gmail.com  
 
Source of Monetary or Material Support  
Vijayanagar Institute of Medical Sciences, Cantonment, Ballari 583104 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Cantonment, Ballari, Karnataka, India 583104 
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 
Dr Rohan S  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology Major OT Complex,Cantonment, Ballari, 583104
Bellary
KARNATAKA 		 9740850950

rohansuresh22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diabetic patients of more than 18 years of age, either of the gender, posted for elective surgeries under anaesthesia with one clear overnight inpatient stay preoperatively.
ASA physical status II and III.
 
 
ExclusionCriteria 
Details  1)Refusal for the procedure.
2)Deviation from proposed fasting times or oral intake advice.
3)Chronic renal failure
4)Liver cell failure
5)Hypothyroidism
6)Cardio-respiratory diseases
7)Current pregnancy
8)Hiatus hernia, intestinal disease, previous upper abdominal surgeries.
9)Patients taking h2 receptor blockers, proton pump inhibitors and prokinetic drugs or any other medication known to delay gastric emptying.
10)Patients prone for aspiration.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of residual gastric volume and contents in diabetic patients posted for elective surgeries by ultrasonography.  After 6 hours fasting for solids and 2 hours for clear fluids gastric volume and contents are assessed at 7 AM 
 
Secondary Outcome  
Outcome  TimePoints 
Qualitative assessment of gastric contents   Basal Gastric content is assessed at 7AM scan. 
To correlate residual gastric volume & contents with:
Duration of diabetes mellitus,
Type of diabetes mellites,
Type of medications,
HbA1C levels,
BMI,
Pre operative duration of fasting,
Type of last meal,
Signs & symptoms of gastropathy.
 		 Ultrasound scan will be done at 7 AM or 2 hours prior to elective surgery, to correlate residual gastric volume & contents with

Duration of diabetes mellitus above 18 years
Type of diabetes mellites, type 1 or type 2.
Type of medications, Oral Hypoglycemic Drugs or Insulin.
HbA1C levels, last 3 months.
BMI,
Pre operative duration of fasting, 6 to 8 hours.
Type of last meal, fatty meal solids & liquids
Signs & symptoms of gastropathy. 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   27/06/2024 
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  

Method of collection of data (Including sampling procedure, if any)

·     Surgical diabetic patients will be explained about the procedure and informed / written consent will be obtained.

·     Thorough pre anaesthetic evaluation is performed and routine investigations will be obtained.

·     They are advised to be nil per oral for both solids and liquids on the previous night of day of scheduled surgery as per ISA fasting recommendations, 6 hours fasting for solid food and non-human milk, 2 hours  for  clear fluids.

·     All the patients will be scanned in recovery room using portable ultrasound machine (Sonosite) with curvilinier probe of low frequency(2-5mhz) set in abdominal scan mode to assess basal gastric volume  and  contents, at around 7AM on the day of surgery before shifting to operating room.

·     Patient will be first scanned in a semi-recumbent (45 degrees head up) supine position, followed by right lateral position (RLP) by keeping the probe in sagittal plane in epigastric region. In both positions, the gastric antrum will be identified above the aorta or inferior vena cava, left lobe of liver anteriorly as reference points. The ultrasonographic examination will be done by the post graduate under the supervision of the guide.

·     A qualitative assessment will be performed to identify content in the stomach (solid or liquid) and gastric antral grading will be done as described by Perlas et al as follows:

           Grade 0= absence of fluid in both supine and RLP; (Bull’s eye sign)

           Grade 1=fluid in RLP only; (starry sky appearance)

           Grade 2=fluid in both supine and RLP/ solid content (ground glass appearance)

Quantitative assessment will be done by measuring antral cross-section area (CSA). 

The antral CSA will be calculated by measuring two perpendicular diameters in longitudinal (d1) and anteroposterior (d2) plane from serosa to serosa and using the formula CSA=π[d1×d2]/4 in supine and RLP.

The following mathematical model will be used to calculate the gastric volume(GV) in ml/kg.

            Volume=27.0+ (14.6×right-lateral CSA) - (1.28×age). 

Patients are categorized into low-risk group for aspiration (empty antrum or residual GV Ë‚1.5ml/kg) and high-risk group (solid contents or GV˃1.5ml/kg)

Detailed history related to duration of diabetes mellites, diabetic medications (oral hypoglycemics or insulin, dose and schedule) symptoms of gastropathy (fullness, heart burn and abdominal bloating), type of last meal, number of fasting hours for solid and liquid diet (previous night) will be obtained. Type of diabetes mellitus, BMI, HbA1C levels, are noted down by the patient clinical records. In the absence of HbA1C level, fasting blood sugar will be noted. The gastric volume and contents are correlated with all these parameters.

 

     

Design of study

Prospective Observational study

 

Mention Sample Size with details

The mean right lateral position gastric volume was 58.63+/- 37.62 in a study conducted by asiye demirel et al. By considering standard deviation [SD] of 37, absolute error or precision [d] of 5 ml with type 1 error 5% and the confidence interval of 95%.

 

Sample size for our study is calculated by the following formula:

 SAMPLE SIZE = Z1-α/22 SD2 /d2                              [ Z1-α/2 = 1.96 AT CI OF 95%]

The calculated sample size is 208

By adding the drop outs of 10% [208 + 28 = 228]

The final sample size will be 230

 
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