FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/11/022139 [Registered on: 25/11/2019] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to find out the volume of the contents of the stomach in patients with kidney failure and fasting before undegoing surgery 
Scientific Title of Study   Ultrasound evaluation of gastric residual volume in fasting end-stage renal failure patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushma K 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital New BEL Road Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  080-40502860  
Fax    
Email  sushmakothapalli55@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejesh CA 
Designation  Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital New BEL Road Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  080-40502860  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushma K 
Designation  PG Resident 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology 2nd floor Ramaiah Medical College Hospital New BEL Road Bangalore


KARNATAKA
560054
India 
Phone  080-40502860  
Fax    
Email  sushmakothapalli55@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore-560054 
 
Primary Sponsor  
Name  MS Ramaiah Medical College 
Address  MSRIT Post New BEL Road Bangalore-560054 
Type of Sponsor  Private 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 
DrSushma K  MS Ramaiah Medical Teaching Hospital  Department of Anaesthesiology 2nd floor Operation theatre complex MS Ramiah Medical Teaching Hospital New BEL Road Bangalore-560054
Bangalore
KARNATAKA 
9945517222

sushmakothapalli55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramiah Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound examination of gastric antrum  In patients with end-stage renal failure who are fasting overnight ultrasound examination of gastric antrum is performed to evaluate the contents and volume 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 20-60 years
Body mass index < 40kg/m2
End-stage renal failure 
 
ExclusionCriteria 
Details  History of upper gastrointestinal disease
Previous surgery on esophagus or stomach
Previous upper abdominal surgery
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate the gastric residual volume and nature of gastric contents  To calculate the gastric residual volume and nature of gastric contents 30 min before anaesthesia induction 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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)   01/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Pulmonary aspiration of gastric contents is a serious perioperative complication. The Fourth National Audit Project by the Royal College of Anaesthetists has reported pulmonary aspiration as the cause of more than 50% of airway-related deaths in anaesthesia. The resulting respiratory compromise is thought to be related to both volume and nature of the aspirate. The most commonly used measure to prevent aspiration is fasting before anaesthesia, and anaesthesia societies have developed guidelines for preoperative fasting. However, these guidelines apply to healthy patients undergoing elective surgery and not reliable in patients with co-morbidities that affect gastric emptying. 

Gastric emptying is known to be delayed in patients with end-stage renal failure. Though certain biochemical markers have been shown to be associated with delayed gastric emptying in patients with chronic renal failure, there is no acceptable method of identifying such patients before anaesthesia. Gastric ultrasound has recently evolved into a simple, point-of-care tool for evaluating gastric content and volume. The gastric antrum can be easily identified using a low frequency curvilinear probe. By visualising the antrum, not only the contents of the stomach can be determined, but also quantification is possible by application of suitable validated methods. There is paucity of literature with respect to the use of gastric ultrasound to determine residual volume in patients with end-stage renal failure. Hence, the present study is designed to evaluate the gastric contents and volume in patients with end-stage renal failure by gastric ultrasound.

 
Close