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CTRI Number  CTRI/2020/03/024005 [Registered on: 16/03/2020] Trial Registered Prospectively
Last Modified On: 05/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Preoperative Ultrasonographic Assessment of Gastric Volume and Fasting Hours 
Scientific Title of Study   Preoperative Ultrasonographic Assessment of Gastric Volume and its Co-Relation with Fasting Hours in Patients undergoing Elective Surgery-A Prospective 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  Dr Sunil N Bodamwad 
Designation  Junior Resident in Anaesthesiology 
Affiliation  LTMMC and LTMGH, Sion 
Address  Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9999938164  
Fax    
Email  drsunil33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Mhamrey 
Designation  Assistant Professor of the Department of Anaesthesiology 
Affiliation  LTMMC and LTMGH, Sion 
Address  Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9930804154  
Fax    
Email  mhambreyshweta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Mhamrey 
Designation  Assistant Professor of the Department of Anaesthesiology 
Affiliation  LTMMC and LTMGH, Sion 
Address  Department of of Anaesthesiology, LTMMC AND LTMGH, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9930804154  
Fax    
Email  mhambreyshweta@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal Medical College and Hospital , Sion, Mumbai, Maharashtra-400022. 
 
Primary Sponsor  
Name  Dr Sunil N Bodamwad 
Address  Room no 102, New RMO Hostel, near LTMMC and LTMGH, Sion, Mumbai, Maharashtra-400022 
Type of Sponsor  Other [SELF] 
 
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 Sunil Bodamwad  Lokmanya Tilak Municipal Medical College and General Hospital   Operation theatres of Department of Emergency,Surgery, Uroplasty, Neurology
Mumbai
MAHARASHTRA 
9999938164

drsunil33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Human Research   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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 and 80 years posted for elective surgery who will be fasted for more than 6 hours for solids and more than 2 hours for clear fluids but not more than 16 hours will be identified in the ward.
2. Such patients giving consent for performing preoperative gastric ultrasound will be included in our study.
 
 
ExclusionCriteria 
Details  1.Pregnant women.
2.Patients with unreliable or unclear fasting history (e.g. language barrier, cognitive dysfunction, altered sensorium)
3.Patients with oesophageal or stomach pathology like achalasia cardia, hiatus hernia, CA oesophagus, CA stomach.
4.Patients who have undergone gastrectomy, gastric bypass surgery.
5.Patients who are unable to turn or lie down in lateral position.
6.Patients on drugs such as prokinetics which alter gastric motility or gastric emptying times. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To preoperatively examine the gastric contents and volume in fasting patients prior to elective surgery by determining the cross sectional area(CSA) of antrum by using bedside ultrasound.
2. To determine the correlation between hours of preoperative fasting and gastric contents and volume.
 
2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   20/03/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Perioperative pulmonary aspiration of gastric contents is a serious complication of anaesthesia and is associated with high morbidity and mortality. It can result in severe pneumonia requiring mechanical ventilator support in up to one-third of patients with a mortality of 5%, representing up to 9% of all anaesthesia-related deaths. The severity of the resulting respiratory compromise is thought to be related to both the volume and nature of the aspirate, with particulate matter carrying the highest risk. Preoperative fasting guidelines help limit the risk in elective patients with minimal co-morbidities. However, fasting intervals are not applicable or reliable in urgent or emergency surgeries or for patients with certain medical conditions. One of the main risk factors for aspiration is the presence of gastric content. The critical volume threshold of gastric fluid that by itself increases aspiration risk is controversial, but healthy, fasted patients frequently have residual gastric volumes (GVs) of up to 1.5 ml/kg without significant aspiration risk.
In anaesthesiology and acute care medicine, there is a growing interest in bedside evaluation of gastric ‘fullness’ to assess pulmonary aspiration risk. With the advent of portable ultrasound machines, performing point-of-care ultrasound has become relatively easy and feasible. Gastric ultrasound examination is finding a place as a point-of-care tool for aspiration risk assessment. It can identify the nature of the gastric content, i.e. empty, clear fluid and solid and when clear fluid is present, its volume can be quantified.
The objective is to determine the correlation between fasting times and gastric content and estimated gastric volume in patients presenting for elective surgery and also to see if the gastric contents and gastric volume are any different in patients with conditions which supposedly predispose them to delayed gastric emptying like diabetes, chronic kidney disease and obesity compared to those without such conditions.
 
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