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CTRI Number  CTRI/2019/02/017677 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 28/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study
Modification(s)  
To study the volume of stomach contents using ultrasound 
Scientific Title of Study
Modification(s)  
Ultrasound-guided estimation of gastric residual volume using Perlas’ formula: A validation study in patients undergoing elective surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Ranganathan 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Room No 210, Main Building Tata Memorial Hospital Ernest Borges Road Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9967971878  
Fax    
Email  drpriyaranganathan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sayali Khandekar 
Designation  Junior Resident 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Room No 210, Main Building Tata Memorial Hospital Ernest Borges Road Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869384848  
Fax    
Email  sayalikhandekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sayali Khandekar 
Designation  Junior Resident 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesiology Room No 210, Main Building Tata Memorial Hospital Ernest Borges Road Parel, Mumbai

Osmanabad
MAHARASHTRA
400012
India 
Phone  9869384848  
Fax    
Email  sayalikhandekar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  No funding 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
Priya Ranganathan  Tata Memorial Hospital  Room 210, Department of Anaesthesia, Main Building, Tata Memorial Hospital, Ernest Borges Road, Parel
Mumbai
MAHARASHTRA 
9967971878

drpriyaranganathan@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee 1 Tata memorial Hospital  Approved 
Institutional Ethics Committee-1, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult healthy volunteers who give consent to participate in the study. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  USG guided estimation  All USG assessments will be performed by 2 trained anaesthesiologists (JRD and PR) who have completed at least 50 such examinations prior to starting the study. At a convenient time during the day, participants will undergo baseline USG guided estimation of GRV. Following this, the investigators (JRD, PR) will be asked to leave the room while the participant consumes a fixed volume of fluid (depending on randomisation arm) Within five minutes (to minimise the effect of gastric emptying), a repeat USG-guided assessment of GRV will be performed. Investigators will be blinded to measurements performed by each other and to the randomisation arm  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  All adult patients who give consent to participate in the study, who are not required to remain fasting (i.e., not posted for surgery or any other procedure which needs fasting)
Exclusion Criteria:
1. Co-morbidities that delay gastric emptying [e.g Diabetics, morbid obesity (BMI>40), Pregnancy, pyloric stenosis]
2. Intestinal obstruction
3. Gastric or Oesophageal malignancy or pathology
4. Therapy with opioids, antacids or prokinetics
5. History of acid peptic disease or gastric reflux.
 
 
ExclusionCriteria 
Details  Refusal of consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure the accuracy of measurement of gastric volume using USG (and Perlas’ formula)   5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) 
 
Secondary Outcome  
Outcome  TimePoints 
1. To examine whether type of fluid – clear (water) or particulate (milk) affects the agreement   5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) 
To look at inter-rater agreement in GRV measurements   5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) 
To examine whether volume of fluid (100 versus 200 ml) affects the accuracy of measurement  5 minutes after consumption of a fixed quantity of water or milk (to be decided by randomization) 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   01/03/2019 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   postgraduate thesis No publication yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
Aspiration of gastric content is a serious perioperative event associated with morbidity and mortality. Patients with a “full stomach” are at increased aspiration risk when sedation or general anaesthesia impair their lower oesophageal sphincter tone and protective airway reflexes. Several studies have used bedside ultrasound to evaluate GRV to assess perioperative aspiration risk and guide anaesthetic management. The purpose of this study is to examine whether the use of bedside ultrasound and Perlas’ formula by trained anaesthesiologists can accurately measure gastric volume in patients undergoing elective surgery who have consumed various quantities of different types of liquids. 
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