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CTRI Number  CTRI/2023/03/050694 [Registered on: 14/03/2023] Trial Registered Prospectively
Last Modified On: 09/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study by using ultrasound to predict feeding intolerance in critically ill patients 
Scientific Title of Study   Assessment of acute gastrointestinal injury (AGI) by point of care ultrasound (POCUS) to predict feeding intolerance in adult critically ill patients- 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 Rakupathy S 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  AB8 ICU, 8th floor, near main OT complex, Department of Anesthesiology, Pain medicine and Critical care, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9965246666  
Fax    
Email  rakupathy90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravinder Kumar Pandey 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5th floor, administative block, Department of Anesthesiology, Pain medicine and critical care, All India Institute of Medical sciences, new Delhi.

South
DELHI
110029
India 
Phone  9773500767  
Fax    
Email  ravindrapandey1972@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakupathy S 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  AB8 ICU, 8th floor, near main OT complex, Department of Anesthesiology, Pain medicine and Critical care, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9965246666  
Fax    
Email  rakupathy90@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical care,AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
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 
Rakupathy S  Intensive Care Unit (AB8 ICU), AIIMS New Delhi  8th floor, AB block (AB 8 ICU) near main OT complex, Department of Anesthesiology, pain medicine and critical care, AIIMS New Delhi.
South
DELHI 		 9965246666

rakupathy90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K904||Other malabsorption due to intolerance,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients aged more than 18 years of age on mechanical ventilation (invasive and non-invasive)
2. ICU stay more than 72 hours
3. Patients planned for enteral nutrition and feeding protocol as per institutional practice
 
 
ExclusionCriteria 
Details  1. Patients with gastrointestinal surgery
2. Patients with abdominal trauma
3. Patients with terminal illness and advanced cancer
4. Patients with pre-existing abdominal pathologies
5. ICU stay less than 72 hours
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the predictive ability of POCUS before initiation of enteral nutrition in adult critically ill patients with feeding intolerance  POCUS will be done at baseline (before EN), 48 hours after enteral nutrition initiation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the 30-day mortality in patients with feeding intolerance
2. To determine the duration of mechanical ventilation, requirement of vasopressors and length of ICU stay in patients with feeding intolerance
 		 30 days from the day of recruitment 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   21/03/2023 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rakupathy90@gmail.com].

  6. For how long will this data be available start date provided 10-07-2025 and end date provided 10-07-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Patients with acute gastrointestinal injury (AGI) have higher mortality than those without AGI. Feeding intolerance (FI) is present in 35-40% of critically ill patients on enteral nutrition. FI is an independent predictor of mortality. Assessment of AGI is usually done by clinical symptoms which lack objectivity. Ultrasound based AGI scores have been developed recently but most of them are complex to use and moreover, none of them are validated in clinical studies. In this study, we are planning to develop a rapid and reliable mode of assessment of AGI with the help of POCUS before initiation of enteral nutrition to predict feeding intolerance in critically ill adult patients.

 
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