| CTRI Number |
CTRI/2024/05/066911 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Assessment of effects of modified digital enteral tube feeding pump over accuracy, safety and patients acceptability compared to conventional method for the cases advised intragastric tube feed. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of modified digital enteral tube feeding pump to facilitate accuracy, safety and patients acceptability as compared to conventional method in cases advised intragastric tube feed. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Savita Pohekar |
| Designation |
Associate Prof. Nursing college , Dept. of medical ,sugical Nursing |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
SRMM, College of Nursing, Sawangi Meghe , wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420063658 |
| Fax |
|
| Email |
savitaak15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ani Wanjari |
| Designation |
Professor, Dept. of Medicine |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Medicine Jawaharlal Nehru Medical College,Sawangi,Wardha,442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422144510 |
| Fax |
|
| Email |
anilwanjari123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Savita Pohekar |
| Designation |
Associate Prof. Nursing college , Dept. of medical ,sugical Nursing |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
SRMM, College of Nursing, Sawangi Meghe , wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420063658 |
| Fax |
|
| Email |
savitaak15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital ,DMIHER, Sawangi,Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education And Research |
| Address |
Datta Meghe Institute of Higher Education And Research, Sawangi ,Wardha , 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ms Savita Pohekar |
Acharya Vinoba Bhave Rural Hospita |
Dept of Medicine,Medical Surgical Ward Acharya Vinobha Bhave Hospital, Sawangi,DMIHER Wardha, 442001
Wardha
MAHARASHTRA |
09420063658
savitaak15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K208||Other esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional enteral tube feeding: |
Conventional enteral tube feeding is the Naso gastric tube feeding using the gravity
or syringe for delivering the intra-gastric feed manually by nurses. This feeding tube not attached with any other device This will be administered for 7 days of patients admitted in the ward. |
| Intervention |
Modified Digital enteral tube feeding. |
Modified Digital enteral tube feeding is the supplementary device for the patients already feed with Ryle’s tube where the mean nutrition taken through the tube that goes directly to the stomach supplemented by the device that is the nasogastric tube feeding using electronic circuit (MCU), which contains display status, control panel-switch, closed
supply unit, valve controller for feed display and flush fluid. Which is connected
with Wi-Fi for patients feed quantity, accuracy flow drop rate and time duration. The
status can be monitored easily automatically which saves the nursing manpower and
can be assessable easily the patients status and the data can be stored through,
internet cloud storage.
This will be administered for 7 days of patients admitted in the ward |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients over 18 years of age admitted to ward and receiving nasogastric
tube feeding. |
|
| ExclusionCriteria |
| Details |
Patients having
Ischemic bowel
Bowel obstruction
Exacerbation of inflammatory bowel disease
Acute variceal bleeding
Patients deemed to be at high risk for anastomotic leak
Patients on mechanical ventilator.
Patients with respiratory diseases
Unconscious patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gastric Residual Volume 0 -50
ml |
At 2 hours and 4 hours after feedings to the patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of Contamination of feeds attributed to use of antibiotic therapy or feed contamination with episodes of diarrhea, dysentery or food poisoning episodes. |
Through day 1 to 7 after feeding |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2024 |
| 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="0"
Months="1"
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 randomized, controlled trial will be going to conduct over a period of one months for 100 sample data collection to compare the intervention and comparator group for finding the results at primary gastric residual volume and secondary outcome contimination episodes to compare the accuracy and safety of the technique .The study will be admired amongst the patients admitted in Tertiary care hospital in Central India AVBRH, Wardha those fulfilling the criteria of inclusion and exclusion. The Institutional ethical committee already approved the proposals but due to covid-19 pandemic study waited to start, at ideal environment for its feasibility. |