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CTRI Number  CTRI/2018/11/016479 [Registered on: 30/11/2018] Trial Registered Prospectively
Last Modified On: 08/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   A study to check stomach volume in patients posted for digestive system surgeries 
Scientific Title of Study   An ultrasonographic analysis of gastric volume in patients posted for elective gastrointestinal surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital  
Address  Department of Anaesthesia Critical care and Pain, Room no MB 210, IInd floor main Building, Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Hospital  
Address  Department of Anaesthesia Critical care and Pain, Room no MB 210, IInd floor main Building, Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Unnathi Manampadi 
Designation  Junior Resident  
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia Critical care and Pain, Room no MB 210, IInd floor main Building, Tata Memorial Hospital, Dr. E Borges Road, Parel Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  9867351517  
Fax    
Email  unnathim@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Research Administrative Council(TRAC), Dr. E. Borges Road, Parel, Mumbai 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E. Borges Marg Parel,Mumbai  
Type of Sponsor  Research institution and hospital 
 
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 Reshma Ambulkar  Tata Memorial Centre- Tata Memorial Hospital &ACTREC   Department of Anaesthesia, Critical Care and Pain, 2nd floor Main building Dr. E. Borges Road, Parel and Department of Anaesthesia 1 st floor, Ward Block Kharghar 410210 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMC-IEC I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable  
Intervention  Screening of gastric volume in patients posted for gastrointestinal surgeries  An ultrasonographic analysis of gastric volume in patients posted for elective gastrointestinal surgeries Intervention  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Age>18yr
2. Patients posted for elective gastrointestinal surgeries. 
 
ExclusionCriteria 
Details  1. Refusal to consent
2. Age>85
3. Emergency surgery including gastric outlet obstruction , bowel obstruction
4. Indications for rapid sequence induction of anaesthesia
5. Pregnancy(13)
6. BMI of <19 or >40(13)
7. Large abdominal mass likely to interfere with US imaging
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing gastric volume using ultrasound in patients posted for elective gastrointestinal surgeries.  Post induction  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2018 
Date of Study Completion (India) 28/11/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Introduction
In anaesthesia practice, respiratory complications such as anaesthesia-related aspiration can be fatal. Incidence of respiratory complications is 1 in every 2–3,000 operations requiring anaesthesia. Almost half of all the patients who aspirate during surgery, develop an aspiration related lung-injury, such as pneumonitis or aspiration pneumonia(1).Preoperative fasting aims at prevention of such perioperative pulmonary aspiration. Preoperative fasting is defined as prescribed period of time before a procedure when patients are not allowed the oral intake of liquids or solids.The American Society of Anaesthesiologists’ (ASA) recommendations for preoperative fasting are followed to prevent this dreaded complication.
In our institute, we follow ERAS protocol in all patients who are posted for elective gastrointestinal surgeries.Our study is an audit of 200 patients to assess the residual gastric volume using ultrasonography and to retrospectively analyse if there is a correlation between residual volume and risk factors of gastroparesis and thereby assess if the fasting guidelines for these patients need to be revisited.

Aim and objective:
To assess gastric volume using ultrasound in patients posted for elective gastrointestinal surgeries.

Patients
The study will involve patients scheduled to undergo elective gastrointestinal surgery.

Sample size
A convenient sample size of 200 patients.

Inclusion criteria:
1. Age>18yr
2. Patients posted for elective gastrointestinal surgeries.

 Exclusion criteria:
1. Refusal to consent
2. Age>85
3. Emergency surgery including gastric outlet obstruction , bowel obstruction
4. Indications for rapid sequence induction of anaesthesia
5. Pregnancy(13)
6. BMI of <19 or >40(13)
7. Large abdominal mass likely to interfere with US imaging

Methodology
After informed consent, patients will be recruited into the study. All the patients in the study would be given clear liquids according to the fasting guidelines.After routine anaesthetic checkup and review of laboratory investigation,we will record any risk factors for gastroparesis.The time since the last meal and last intake of clear liquids will be noted.
In our study, we will assess the gastric volume of patients posted for elective gastrointestinal surgeries by ultrasonography, post induction of anaesthesia. The method of induction will be as per the discretion of the OT anaesthetist.After quantitative assessment of gastric volume,we will do a retrospective analysis if there is any correlation of increased gastric volume with risk factors leading to gastroparesis. Also we will see if there is any negative correlation i.e. gastric volume <1.5ml/kg in the presence of risk factors for gastroparesis.
1 operator [intensivist experienced in abdomen ultrasonography(14)] will assess the gastric volume post induction with ultrasonography. After induction, the patient will be positioned in the right lateral decubitus position.A curved array low-frequency transducer (2– 5 MHz) with standard abdominal settings will be used to identify the relevant anatomic landmarks and a curvilinear high-frequency transducer will be used to obtain detailed images of the gastric wall. Our site of assessment will be gastric antrum.It is found superficially between the left lobe of the liver anteriorly and the pancreas posteriorly in a sagittal or para- sagittal scanning plane in the epigastrium. Important vascular landmarks including both the aorta or inferior vena cava (IVC) and either the superior mesenteric artery or vein can be used to standardize a scanning plane through the antrum.
Quantitative assessment will comprise of taking antral CSA (cross section area) by measuring 2 perpendicular diameters i.e. AP = antero-posterior diameter and CC = craniocaudal diameter and the formula of the area of an ellipse will be applied
CSA = (AP×CC ×π)/4
(AP = antero-posterior diameter and CC = craniocaudal diameter).

The model used for assessment will be: Perlas and colleagues(13)

Formula : Gastric Volume (ml)=27.0+14.6×right-lateral CSA(cm2)-1.28×age (yr)

Statistical analysis:
The gastric volume will be categorized into two groups. The group one is <=1.5ml/kg and other group is >1.5 ml/kg. Categorical data will be presented as counts and percentages. Correlation between gastric volume and risk factors of gastroparesis in patients posted for elective gastrointestinal surgeries will be compared using Chi-square test or Fisher-exact test as appropriate. Statistical significance will be defined as p<0.05.








 
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