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CTRI Number  CTRI/2024/07/071278 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [METHOD OF GIVING RYLES TUBE FEEDING IN CRITICALLY ILL PATIENTS]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare efficacy and safety of continuous and intermittent Ryles tube feeding in critically ill patients in terms of achieving target nutrition goal and tolerance of feed. 
Scientific Title of Study   Continuous versus intermittent enteral tube feeding for critically ill patients A prospective randomized comparative trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Bhupendra kumar tiwari 
Designation  Post graduation student 
Affiliation  FORTIS ESCORTS HOSPITAL,JAIPUR 
Address  Department of critical care, Fortis Escorts hospital ,Malviya nagar ,Jaipur

Jaipur
RAJASTHAN
302018
India 
Phone  7597905970  
Fax    
Email  drbhupendratiwari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaibhav Bhargava 
Designation  Senior consultant,critical care 
Affiliation  FORTIS ESCORTS HOSPITAL,JAIPUR 
Address  Medical ICU 3,Department of critical care, ,Fortis Escorts hospital ,Malviya nagar,Jaipur

Jaipur
RAJASTHAN
302018
India 
Phone  9928787788  
Fax    
Email  drvaibhav79@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VAIBHAV BHARGAVA 
Designation  SENIOR CONSULTANT,CRITICAL CARE 
Affiliation  FORTIS ESCORTS HOSPITAL,JAIPUR 
Address  MICU 3,DEPARTMENT OF CRITICAL CARE, FORTIS ESCORTS HOSPITAL,MALVIYA NAGAR,JAIPUR


RAJASTHAN
302018
India 
Phone  9928787788  
Fax    
Email  drvaibhav79@gmail.com  
 
Source of Monetary or Material Support  
Fortis Escorts hospital,Malviya nagar,Jaipur,Rajasthan,India PIN CODE:302018  
 
Primary Sponsor  
Name  Fortis Escorts hospital Jaipur 
Address  Malviya nagar, Jaipur, Rajasthan, India PINCODE:302018 
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 Bhupendra kumar tiwari  Fortis Escorts hospital Jaipur   Medical ICU, Department of critical care
Jaipur
RAJASTHAN 		 7597905970

drbhupendratiwari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,fortis escorts hospital,jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous enteral tube feeding  Starting enteral feed 25ml/hour, for 20 hours a day and increasing feed till target nutrition goal is achieved. 
Comparator Agent  Intermittent enteral tube feeding   4 hourly 5 times a day ,starting from 100ml per feed and increasing feed till target nutritional goal is achieved. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Adult patients 18 to 80 years admitted to the intensive care unit (MEDICAL ICU)
2.Patients receiving mechanical ventilation,who expected to require ventilation for greater than or equal to72 hrs and where to start enteral tube feeding with in 48 hrs of the icu admission.
3.Hemodynamically stable patients.
4.BMI is 18 to 50
5.Patient’s relative giving consent
 
 
ExclusionCriteria 
Details  1.Patients with contraindications to enteral feeding, such as severe diarrhea greater than one litre in 24hrs,acute pancreatitis,bowel ischemia,bowel obstruction,history of upper GI surgery,malabsorption syndrome,GI bleeding,short bowel syndrome.
2.Pregnancy or lactation.
3.Presence of a percutaneous endoscopic gastrostomy (PEG) or jejunostomy tube.
4.Anticipated need for surgical intervention during the study period.
5.Hypersensitivity reactions to prokinetic agents
6.Abdominal surgery with in one month.
7.Difficulty in placement of nasogastric or orogastric tube.
8.Ongoing enteral nutrition on admission to MICU.
9.Patient’s relatives not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be Mean duration to achieve at least 70% of the target nutrition requirement after the start of enteral feeding(in hours). The achievement rate will be calculated as the number of days in which at least 70% of the target nutrition requirement is achieved divided by the total number of days of feeding days. Gastrointestinal intolerance during the first 7 days after the start of enteral feeding   Enteral feeding will be initiated with in 48 hours of ICU admission after randomization.Target nutrition will be achieved as early as possible and study will monitor patient for seven days for target achieved. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoints will include ICU mortality, 28-day mortality, length of stay in the ICU and hospital   Secondary endpoints will include ICU mortality, 28-day mortality, length of stay in the ICU and hospital  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2 
Date of First Enrollment (India)   10/08/2024 
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 Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 11-08-2025 and end date provided 11-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   NUTRITION IS IMPORTANT PART FOR TREATMENT OF CRITICALLY ILL PATIENTS.METHOD OF NUTRITION IN CRITICALLY ILL PATIENTS IS ALWAYS DEBATABLE.ENTRTAL FEEDINF IS PREFFERED OVER PARENTERAL FEEDING.IN ENTERAL FEEDING INTERMITTENT FEEDING IS MORE PHYSIOLOGICAL BUT CONTINUOUS FEEDING MAY BE MORE TOLERABLE.IN INDIA THERE HAS NOT BEEN ANY STUDY TO PROVE THIS. 
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