Comparision of The Effect of Enteral Feeding ThroughThe Bolus & Continuous Methods on Paraclinical Outcome & Incidence of Diarrhea in Patient With Mechanical Ventilation
Effect of bolus and continuous enteral feeding on laboratory parameters and incidence of diarrhea in patients with mechanical ventilation
Design
The clinical trial has a control group, with parallel groups, single blind, randomized, phase 3 trial with a sample size of 34 patients.
Settings and conduct
Patients admitted to the intensive care unit of imam Khomeini hospital of Tehran who were eligible for inclusion in the study were divided into two study groups.in the intervention group, the patient started feeding at 25 cc / h and in the control group at 75cc / 3h.On the first day of gavage, we reached 50% of the patient's nutritional goal and within 48 hours we reached the final goal of feeding the patients at 25kcal / kg / day.the incidence of diarrhea during one week was recorded in both groups. At the end of one week of intervention, albumin, phosphate and lactate were measured and pre-albumin was measured 48 hours after intervention. Glucose index was also checked and recorded every 6 hours during the intervention.blinding was performed unilaterally (participants).
Participants/Inclusion and exclusion criteria
Inclusion criteria:-The patient's intubation through the tracheal tube- Feeding the patient through the gastric tube- Patient companions' consent to participate in the study- Ages 18-85- Body mass index between 18-30Exclusion criteria:- Having diarrhea at the beginning of the study- Having bowel and ileus obstruction- Being diagnosed with kidney failure- Having an ileostomy and a colostomy
Intervention groups
Intervention group: continuous enteral feeding
Control group: bolus enteral feeding
Main outcome variables
Determination and Comparison of Albumin, Phosphate, Pre-Albumin, Lactate and Blood Glucose Levels in Patients Under Mechanical Ventilation in the Bolus and Continuous Nutrition Group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042528N1
Registration date:2020-01-18, 1398/10/28
Registration timing:retrospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Javad Seyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3632 4105
Email address
jseyedi30@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2018-10-06, 1397/07/14
Actual recruitment end date
2019-09-11, 1398/06/20
Trial completion date
2019-09-21, 1398/06/30
Scientific title
Comparision of The Effect of Enteral Feeding ThroughThe Bolus & Continuous Methods on Paraclinical Outcome & Incidence of Diarrhea in Patient With Mechanical Ventilation
Public title
Effect of Enteral Feeding on Paraclinical Outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with mechanical ventilation throught the endotracheal tube
Feeding of Patient with NG tube
Patient attendant satisfaction
18-85 years old
Exclusion criteria:
Patient with digestive Disease( diarrhea, ileus, obstruction, ostomy)
Patient with renal failure
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants are randomly assigned to study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical scinces
Street address
No.1,Langroudi Ave.,Imam Khomeyni Blvd
City
Tehran
Province
Tehran
Postal code
1319847858
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.TUMS.FNM.REC.1397.103
Health conditions studied
1
Description of health condition studied
Paraclinical changes in continuous feeding and bolus feeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum albumin level
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
Analysis by Bromocresol Green Pars Test Laboratory Kit
2
Description
Serum level of pre-albumin
Timepoint
Before the intervention and 2 days after the intervention
Method of measurement
Analysis by Nephlometry Laboratory Kit Brand Binding site
3
Description
Serum phosphate level
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
Photometric analysis uv test
4
Description
Serum lactate level
Timepoint
Before the intervention and 7 days after the intervention
Method of measurement
Enzymatic / colorimetric analysis kit by Fars Bayer Lab
5
Description
Frequency of defecation
Timepoint
During 7 days of intervention
Method of measurement
View and record in data log sheet
6
Description
Patient's blood sugar
Timepoint
Every six hours
Method of measurement
clever check Glucometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients in this group received continuous enteral feeding with standard commercial solution of enterameal of karen group. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient started feeding at 25cc / h in a semi-seated position. And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study ...
Category
Treatment - Other
2
Description
Control group: Patients in this group received enteral feeding through routine (bolus) and with standard commercial enterameal solution. After adding 11.3 g of powder to 50 cc of water, each cc contains one kcal of energy. In this method, the patient started feeding at a rate of 75cc / 3h in a semi-sitting position And every three hours the volume of gastric residue was measured, and if the volume of gastric residue was less than 50% of the volume of the patient's previous three hours, the patient's gavage was continued and the patient's gavage volume was increased in calories, if any. When the volume of the stomach was more than 50% of the volume of gavage in the last three hours, the patient's gavage was cut for three hours. On the first day of the patient's gavage, 50% of the patient's nutritional intake was met, and within 48 hours we reached the final nutritional goal of 25kcal / kg / day, and continued with the same target volume until the end of the study ...
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Javad Seyyedi
Street address
No.1,Langhroudi Al., Imam Khomeini Ave.,
City
Tehran
Province
Tehran
Postal code
1319847858
Phone
+98 21 6638 7619
Email
jseyedi30@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraian
Street address
Qods Ave., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Seyyedi
Position
Master of Scince Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Langhroodi Al., Imam Khomeini Ave.,
City
Tehran
Province
Tehran
Postal code
1319847858
Phone
+98 21 6638 7619
Email
jseyedi30@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Seyyedi
Position
Master of Scince Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Langhroodi Al., Imam Khomeini Ave.,
City
Tehran
Province
Tehran
Postal code
1319847858
Phone
+98 21 6638 7619
Email
jseyedi30@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Seyyedi
Position
Master of Scince Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Langhroodi Al., Imam Khomeini Ave.,
City
Tehran
Province
Tehran
Postal code
1319847858
Phone
+98 21 6638 7619
Email
jseyedi30@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only original data is shared
When the data will become available and for how long
1 year after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Comparison with data from similar studies
From where data/document is obtainable
jseyedi30@yahoo.com
What processes are involved for a request to access data/document