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Comparison of the effect of two methods of bolus and continuous enteral feeding on biochemical and clinical indicators of trauma patients admitted to intensive care units

Protocol summary

Study aim
Comparison of continuous and bolus nasogastric feeding on biochemical and clinical indicators of trauma patients admitted to ICU
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Researchers will refer to Shahid Beheshti Hospital after obtaining permission from the Vice Chancellor for Research and the Ethics Committee of the University of Medical Sciences.according to the patient's conditions who are'nt able to give written consent to participate in the study, his legal guardian will be obtained after stating the objectives of participation in the study.Preparing and performing the intervention:Intestinal feeding in the form of blues for 10-20 m using a 50 cc syringe .The amount of gavage solution in 24h, which is determined based on volume, calories and tolerance.In the continuous feeding group through a feeding pump, a special food bag every 4-6 h, 20-50 cc/h, which is determined based on volume, calories and tolerance
Participants/Inclusion and exclusion criteria
Inclusion criteria:1- 8-60 years.2- Being hospitalized in the ICU.3-Intestinal nutrition through the nasogastric tube.4-The patient isn't in critical condition.5-trauma.6-No renal or liver impairment;Exclusion criteria:1-Nasogastric tube exit.2- Intravenous feeding .3-The patient's intestinal feeding be stopped for some reasons for˃ 24 h.4- changes of gavage solution .5-Death of the patient,surgery.6- Reluctance to continue cooperation on behalf of the patient's guardian
Intervention groups
continuous feeding( Intervention)-bolus feeding(Control)
Main outcome variables
Biochemical :Alb,total pr,WBC,whole blood lymphocytes,Hb,htc,ur,cr,Ca,P,mg;Clinical:the number of bowel movements and remaining volume ˃150 ml, aspiration, gastric bleeding,vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100124003146N10
Registration date: 2022-07-19, 1401/04/28
Registration timing: prospective

Last update: 2022-07-19, 1401/04/28
Update count: 0
Registration date
2022-07-19, 1401/04/28
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of bolus and continuous enteral feeding on biochemical and clinical indicators of trauma patients admitted to intensive care units
Public title
Comparison of two methods of bowel feeding and continuous in intensive care patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being hospitalized in the intensive care unit Intestinal feeding through the nasogastric tube is prescribed by a doctor Have stable and normal hemodynamic conditions. The patient has a head trauma.
Exclusion criteria:
Age over 60 years The patient has intravenous nutrition The patient has a kidney or liver disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method was used in blocks 4 and 6, which were prepared using the online randomization software (www.sealedenvelope.com). In this software, two groups A (continuous feeding group) and B (bolus feeding group) were defined. Then, according to the total number of samples, which was 74, to increase the validity of randomization, two blocks of 6 and 4 blocks were defined with the approval of a statistician.Then, the researcher will be present in the section and will put the samples with the word criteria into groups based on the list obtained from the randomization software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, nurses will only be aware of the type of gavage for the patient, but will not know which patient is in the experimental group and which patient is in the control group. Also, the person who collects the study data and the person who will analyze them will not know the names of the groups and only the names of the groups will be marked with the letters A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Nursing and Midwifery, Health and Paramedicine - Kashan Universit
Street address
5th kilometer Qotb Ravandi blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1401.023

Health conditions studied

1

Description of health condition studied
Nutritional support in intensive care
ICD-10 code
E43
ICD-10 code description
Unspecified severe protein-calorie malnutrition

2

Description of health condition studied
Nutritional support in intensive care
ICD-10 code
J98.4
ICD-10 code description
Other disorders of lung

Primary outcomes

1

Description
Remaining volume in the stomach
Timepoint
Daily
Method of measurement
Gavage syringe(50 cc)

2

Description
level of Albumin
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry test device

3

Description
Number of intestinal excretions
Timepoint
daily
Method of measurement
checklist

4

Description
Occurrence of pulmonary aspiration
Timepoint
daily
Method of measurement
checklist

5

Description
Number of vomiting
Timepoint
daily
Method of measurement
checklist

6

Description
Stomach bleeding
Timepoint
daily
Method of measurement
checklist

7

Description
Total blood protein level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry test device

8

Description
White blood cell level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood analyzer

9

Description
Whole blood lymphocyte count
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood analyzer

10

Description
Blood hemoglobin level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood analyzer

11

Description
Hematocrit level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood analyzer

12

Description
blood urea level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry test device

13

Description
Blood creatinine level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

14

Description
Blood calcium level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

15

Description
Blood phosphorus level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

16

Description
Blood phosphorus level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

17

Description
Blood cholesterol level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

18

Description
Blood triglyceride levels
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

19

Description
Blood aspartate aminotransferase level
Timepoint
Before intervention, 3 and 7 days after intervention
Method of measurement
Blood biochemistry device

Secondary outcomes

1

Description
weaning from the ventilator
Timepoint
End of intervention
Method of measurement
Checklist

Intervention groups

1

Description
The enteral nutrition group will be the intervention group in a continuous manner. In the intervention group, enteral feeding will be done continuously (for 24 hours and in the form of an infusion of 20 drops per minute, which will be 2000 cc for a total of 24 hours). The food item (Karen's Standard Intermeal powder) will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days.
Category
Treatment - Other

2

Description
The control group will be given enteral feeding in the form of bolus using a gavage syringe and under gravity every 3 hours, 250 cc of food will be given in 10 to 20 minutes, for a total of 24 hours of 2000 cc of standard Intrameal solution dissolved by a nutritionist. , will be given. The food item (Karen's Standard Intermeal powder) which will be prepared and given by the nutrition expert in a standard way for both groups in the same volume every 24 hours. The duration of intervention in both groups will last seven days.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital of kashan
Full name of responsible person
Ismail Azizi-Fini
Street address
5th kilometer Qotb Ravandi Blouvar.Parastar blouvar
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5510 3136
Email
azizifinies@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Banafshe
Street address
5th Kilometer Qotb Ravandi.Kashan university of medical sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5546 1032
Email
Azizi-es@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizifinies@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Azizi-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizifinies@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ismail Aziz-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizifinies@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
the results related to the main outcome will be distributed
When the data will become available and for how long
after the publication of the article
To whom data/document is available
All people
Under which criteria data/document could be used
data will be confidential
From where data/document is obtainable
azizifinies@yahoo.com
What processes are involved for a request to access data/document
En the process will be announced later
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