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CTRI Number  CTRI/2020/03/024083 [Registered on: 19/03/2020] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Ultrasound of the stomach before operation to see it’s contents in the fasting patients scheduled for surgery  
Scientific Title of Study   Point of care gastric ultrasound (POCGUS) for the assessment of preoperative gastric residual volume in fasting patients scheduled for elective surgery - An observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chaitra T S 
Designation  Postgraduate student 
Affiliation  Government medical college and hospital 32 , Chandigarh  
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9482911971  
Fax    
Email  drchai94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Palta 
Designation  Professor  
Affiliation  Government medical college and hospital 32 , Chandigarh  
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121523  
Fax    
Email  sanjeev_palta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Richa Saroa 
Designation  Associate Professor  
Affiliation  Government medical college and hospital 32 , Chandigarh  
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121513  
Fax    
Email  richajayant@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care,GMCH,Chandigarh  
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive care  
Address  Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh CHANDIGARH 160030 India 
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 
Chaitra T S  Government medical college and hospital,Chandigarh   Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH , sector 32, Chandigarh CHANDIGARH 160030 India
Chandigarh
CHANDIGARH 
9482911971

drchai94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee, GMCH, Chandigarh  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients of either sex aged between 18 to 80 years.
2. American Society of Anaesthesiologists status I-II.
3. Patients scheduled for elective surgery. 
 
ExclusionCriteria 
Details  1. Patients with history of prior gastric or lower esophageal surgery
2. Patients with known abnormalities of the upper gastrointestinal tract (such as hiatal
hernias and gastric tumors)
3. Pregnancy
4. Patients unable to turn and lie in lateral position
5. Patients with BMI more than 35kg/m2
6. Patients who are not able to understand the study procedure and provide informed written
consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To use point of care gastric ultrasound for assessing the preoperative gastric residual volume in patients scheduled for elective surgery   After 8 hours of fasting 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the measured gastric volume with hours of fasting
2. To find correlation between the measured gastric volume with any underlying comorbidities  
After 8 hours of fasting 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "409"
Final Enrollment numbers achieved (India)="409" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2020 
Date of Study Completion (India) 21/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None as yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
 Pulmonary aspiration of gastric contents is a rare but, a serious complication of anaesthesia. Significant pulmonary complications happens in almost half of patients who aspirate and almost 50% of deaths in anaesthesia are directly due to aspiration of gastric contents, which occurs more commonly in patients with risk factors, at the time of induction of anaesthesia or during airway instrumentation. The presence of gastric contents increases the risk of aspiration and as a result practice guidelines for preoperative fasting have been designed to provide adequate time for gastric emptying in patients undergoing surgery.
The practice guidelines of American Society of Anesthesiologists (ASA) for healthy adults consider a minimum fasting duration of 2 hrs for clear fluids, 6 hrs for a light meal and 8 hrs for a fatty meal, fried foods or meat to be safe. However , uncertainty still exists regarding the exact gastric residual volume(GRV) that places the patients at increased risk of aspiration despite following standard fasting guidelines.
Many techniques have been described to assess the gastric contents like gastric content aspiration,  paracetamol absorption, electrical impedance tomography, radio labelled diet, magnetic resonance imaging and the gold standard being gastric scintigraphy. Each modality has its pros and cons. Gastric ultrasound will be performed using a low frequency curvilinear array probe. With the advent of newer portable ultrasound (US) machines, it is possible to accurately assess the gastric contents non- invasively. Antrum It is the region of the stomach which is most amenable to ultrasonographic examination and also the portion which is most consistently identified (98- 100% cases) on ultrasonography (USG). Antral cross sectional area (CSA) calculated from gastric ultrasound highly correlates with scintigraphy and therefore cross sectional area of gastric antrum accurately predicts gastric fluid volume with the same precision as scinitgraphy. It thus helps the anaesthetist to anticipate the aspiration risk at bedside and guide anaesthetic and airway management more appropriately. Scanning was first done in the supine position followed by right lateral decubitus position. According to the appearance of the contents , qualitative assessment was done followed quantitative analysis. For the latter , antral cross sectional area (ACSA) was measured at the level of the aorta using ultrasound machine. All images were obtained between peristaltic contractions of the antrum. ACSA was measured in right lateral decubitus position using traditional two diameter method (TDM) . This involved measuring two perpendicular diameters of the antrum, from serosa to serosa, longitudinal or craniocaudal (CC), and the anteroposterior (AP) using the formula developed by Bolondi et al  in which
ACSA = (CC × AP) × π) / 4, with π value = 3.14. Later, using ACSA , gastric volume was calculated using the formula,
Gastric volume (mL) = 27 + 14.6 ACSA (cm2) - 1.28 age (years) which is given by Perlas et al.
Hence, the  present study was undertaken to ascertain the gastric residual volume (GRV) by point of care gastric ultrasound  in fasting patients scheduled to undergo elective surgery and correlated the same with the hours of fasting and any underlying co-morbidities. 
 
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