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CTRI Number  CTRI/2025/10/095923 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   We want to find out which method of giving liquid food through a tube works best and is safest for very sick patients in the ICU between slow continuous feeding smaller regular meals and larger meals. 
Scientific Title of Study   A randomized controlled trial to compare the efficacy and safety of continuous, intermittent and bolus enteral feeding in critically ill patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aravind B Guledagudd  
Designation  DM Critical Care Medicine senior resident 
Affiliation  Bangalore Medical College and Research Institute  
Address  ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI K R Road, Fort, Bangalore Bangalore KARNATAKA India

Bangalore
KARNATAKA
560002
India 
Phone  9731001434  
Fax    
Email  aravindbg2012@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Vijayakumar H N  
Designation  Professor and Head, Department of Critical Care Medicine 
Affiliation  Bangalore Medical College and Research Institute  
Address  ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI K R Road, Fort, Bangalore Bangalore KARNATAKA India

Bangalore
KARNATAKA
560002
India 
Phone  9886504680  
Fax    
Email  viji2751977@gmail.com   
 
Details of Contact Person
Public Query  
Name  Aravind B Guledagudd  
Designation  DM Critical Care Medicine senior resident 
Affiliation  Bangalore Medical College and Research Institute  
Address  ICU 5TH Floor, Trauma and Emergency Care Centre, BMCRI K R Road, Fort, Bangalore Bangalore KARNATAKA India

Bangalore
KARNATAKA
560002
India 
Phone  9731001434  
Fax    
Email  aravindbg2012@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute, Karnataka, India - 560002  
 
Primary Sponsor  
Name  Department of Critical Care Medicine  
Address  5th floor, Trauma and Emergency care centre, Bangalore Medical College and Research Institute, K R Road, Fort, Bangalore, Karnataka - 560002  
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 
Dr Aravind B Guledagudd  Bangalore Medical College and Research Institute   Department of Critical Care Medicine, 5th floor, Trauma and Emergency Care Centre, BENGALURU
Bangalore
KARNATAKA 		 9731001434

aravindbg2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTES ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bolus enteral tube feeding  The feed will be introduced via Ryle’s tube under the flow of gravity with the help of the siphoning technique and 300ml of volume according to calorie requirement of individual patients will be given over a period of 4 minutes for 4 times a day mimicking a physiological feeding regimen 
Comparator Agent  continuous enteral tube feeding   the feed will be introduced via Ryle’s tube under the flow of gravity with the help of the feeding bag continuously at 50 mL/h for 24 hours 
Comparator Agent  Intermittent enteral tube feeding  In the intermittent feeding, 200ml of volume will be introduced via Ryle’s tube under the flow of gravity over a period of 20 mins for 6 times a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who are on tube feeding with normal gastric function admitted in ICU
Who had given informed consent 
 
ExclusionCriteria 
Details  Short bowel
Severe Acute pancreatitis
Post intestinal surgery
Intestinal failure
High/triple ionotropic support.
The patients who died or got discharged before 48 hours of initiation of feeding
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients.  To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients at day1,day2,day3 
 
Secondary Outcome  
Outcome  TimePoints 
To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients.  To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients at day1, day2, day3 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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)   21/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  aravindbg2012@gmail.com

  6. For how long will this data be available start date provided 13-10-2025 and end date provided 13-10-2025?
    Response - Immediately following publication. No end date.

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

Enteral nutrition (EN) delivers nutrition directly into the gastrointestinal tract and is preferred over parenteral nutrition (PN) due to its physiological benefits, preservation of gut integrity, lower complication risks, and immune advantages. It is widely used in acute, sub-acute, rehabilitation, and long-term care settings, and can be administered as continuous, cyclic, intermittent, or bolus feeding. Intermittent feeding, usually given over 20–60 minutes four to six times daily, is more physiological and allows patient mobility, but carries risks such as aspiration, diarrhea, and gastric distension. Bolus feeding, delivered rapidly via syringe or gravity drip three to six times daily, mimics normal meal patterns and enhances patient independence, though it may increase aspiration risk and cause osmotic diarrhea or delayed gastric emptying with certain formulas.

For critically ill patients, including those intubated, with poor glycemic control, receiving jejunal feeds, or unable to tolerate intermittent schedules, continuous EN via a pump or gravity bag at a set hourly rate is often preferred. Continuous feeding improves tolerance, reduces gastric residuals, and decreases aspiration risk but requires specialized equipment, restricts mobility, and increases costs. Comparative studies suggest continuous feeding offers better tolerance and lower gastric residuals than intermittent or bolus methods, though intermittent and bolus feeding are more physiological. However, no single study has compared all three methods directly, highlighting the need for further research.

 
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