| CTRI Number |
CTRI/2025/09/094307 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two feeding methods, intermittent and bolus, to see which method is better tolerated among critically ill patients admitted in JIPMER hospital, Puducherry. |
|
Scientific Title of Study
|
Effect of intermittent versus bolus enteral feeding on feeding tolerance among critically ill patients at a tertiary care centre, Puducherry- A Randomized Controlled Trial |
| Trial Acronym |
NL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Ramamoorthy |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, JIMPER |
| Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843299340 |
| Fax |
|
| Email |
laxmi_ramamoorthy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Ramamoorthy |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, JIMPER |
| Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843299340 |
| Fax |
|
| Email |
laxmi_ramamoorthy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nappi Bamin Mortii Yamang |
| Designation |
Student |
| Affiliation |
College of Nursing, JIPMER |
| Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8119915639 |
| Fax |
|
| Email |
baminnappi5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate and Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
Intramural Research Fund Committee, JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Puducherry
Pin code- 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshmi Ramamoorthy |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Anesthesiology and Critical Care, Critical Care Unit, Ward 21
Pondicherry
PONDICHERRY |
9843299340
laxmi_ramamoorthy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Interventional Studies JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z998||Dependence on other enabling machines and devices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus enteral feeding |
Connect a 50cc syringe with a nasogastric tube and introduce the feed and allow the feed to free flow. At the end of the feeding, flush the tube with 10 mL of water to prevent clogging of tube.
The feed will be completed in 5-10 minutes. |
| Intervention |
Intermittent enteral feeding |
Targeted amount of feed will be introduced into the Romsons feeding bag and hung 3 feet above the level of the patient using an IV stand. The transfer set will be connected to the nasogastric tube, the roller controller will be adjusted and feeding will be started.
It will comtinue for 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Mechanically ventilated patients
2. Patients admitted to the Critical Care ICU of JIPMER, Puducherry
3. Inability to swallow food orally and having indication for nasogastric tube feeding
4. Hemodynamically stable patients |
|
| ExclusionCriteria |
| Details |
1. Development of ability to eat orally during the study
2. Need for any urgent diagnostic or therapeutic procedure that requires nil per oral
3. Presence of fistula, obstruction and surgery of the gastrointestinal system |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of intermittent versus bolus feeding on enteral feeding tolerance of critically ill patient |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To assess the effectiveness of intermittent vs bolus enteral feeding methods i achieving targeted nutrition
- To associate the effectiveness of intermittent vs bolus feeding on enteral feeding tolerance with the clinical characteristics of the patients. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
17/09/2025 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized controlled trial on the effect of intermittent versus bolus enteral feeding on feeding tolerance among critically ill patients at JIPMER Puducherry. Patients who meet the inclusion criteria will be divided into two groups through block randomization.
Preparatory phase includes elevating the head of the bed at least 45 degrees to prevent aspiration and preparing articles required for intermittent and bolus feeding. Placement of tube will be confirmed by aspiration and air insufflation with stethoscope.
In intermittent feeding the targeted amount will be given through a feeding bag hung above the bed using a roller controller for one hour. In bolus feeding a syringe will be connected to the nasogastric tube and the feed will be given within 5 to 10 minutes followed by flushing with water.
Feeds will be given six times daily for five days. Gastric residual volume will be checked before every feed using a syringe. If residual volume is more than 50 percent of previous feed or above 250 ml the next feed will be withheld. If volume is below 250 ml it will be discarded and the next feed will be given.
Outcome measure will include gastric residual volume, abdominal distention, vomiting, diarrhea, constipation and achievement of targeted nutrition. Patients will be observed in semi fowlers or elevated position after feeding to reduce regurgitation and aspiration.
|