The aim of the present study is implementing changes in the time interval in bolus method feeding, for proposing a proper diet to reduce the occurrence of intolerance in Intensive Care Unit hospitalized patients. The study population in this clinical trial is patients who are admitted in general intensive care unit of Hamedan Besat Hospital. 63 participants are selected from the patients and will be exposure the intervention. For participants are necessary to be 18 years old or more, have endotracheal tube and to be under bolus method NG-tube nutrition. Also participants are excluded in the case of death or transfer of the unit or to be made NPO due to the diagnostic and therapeutic procedures. Then the patients were randomly divided into three feeding groups with SPSS software. In the first group formula every 2 hours with 200 ml volume, in the second group formula every 3 hours with 300 ml volume and in the third group formula every 4 hours with 400 ml volume will be administrated. The formula and the feeding method is similar in all 3 groups. Before entering the study, Acute Physiology And Chronic Health Evaluation ‖ and Glasgow Coma Scale will be used to determine the severity of the condition and level of consciousness. In every groups (2, 3 or 4 hours), this feeding designated schedule will be done for three days. During these three days intolerance complications include regurgitation, diarrhea and gastric residual volume will be controlled and recorded by the trained nurse or the investigator, finally the intolerance complications will be compared in different intervals and appropriate diet will be recommended.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081718832N1
Registration date:2015-05-16, 1394/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Samaneh Sadeghi Hedayat
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 813839472
Email address
s.sadeghihedayat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of nasogastric feeding intervals on feeding tolerance in Intensive Care Unit patients
Public title
Effect of time interval on feeding tolerance in ICU patients
Purpose
Supportive
Inclusion/Exclusion criteria
Patients are eligible for inclusion if they: are nasogastric tube fed via Bolus infusion; ≥18 years of age; are expected to have an ICU length of stay (LOS) >3days; don’t have diabetic disease, renal /hepatic failure because they need special formulas such as diabetic formula, hepatic formula; patients who are not immunocompromised; don’t have gastrointestinal diseases or surgery during recent 6 weeks; don’t have drug abuse history; don’t use drugs that increase gastrointestinal motility; don’t have diarrhea before the study. Participants are excluded from the study if they: need gastrointestinal motility enhancing drugs; change of feeding methods or formula during study; have gastric residual volume more than 200 ml; have gastrointestinal complications by another reasons; die or transfer from ICU to another wards; be made NPO due to the diagnostic and therapeutic procedures
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmide Boulevard, Hamedan
City
Hamedan
Postal code
38698-65178
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
پ/16/35/9/6169
Health conditions studied
1
Description of health condition studied
diarrhoea
ICD-10 code
K59.1
ICD-10 code description
Functional diarrhoea
2
Description of health condition studied
regurgitation
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
3
Description of health condition studied
high gastric residual volume
ICD-10 code
R19.8
ICD-10 code description
Other specified symptoms and signs involving the digestive system and abdomen
Primary outcomes
1
Description
regurgitation
Timepoint
during 24 hours for 3 days
Method of measurement
inspection
2
Description
dification
Timepoint
during 24 hours for 3 days
Method of measurement
inspection
3
Description
gastric residul volume
Timepoint
every 4 hours during 3 days
Method of measurement
using 60 ml syring
Secondary outcomes
1
Description
pulse rate
Timepoint
every 3 hours
Method of measurement
monitoring system
2
Description
systolic blood pressure
Timepoint
every 3 hours
Method of measurement
monitoring system
3
Description
diastolic blood pressure
Timepoint
every 3 hours
Method of measurement
monitoring system
4
Description
body temprature
Timepoint
every 3 hours
Method of measurement
Mercurial thermometer
Intervention groups
1
Description
1st group: enteral nutrition via bolus infusion every 2 hours with 200 ml volume of standard formula for 3 days
Category
Prevention
2
Description
2nd group: enteral nutrition via Bolus infusion every 3 hours with 300 ml volume of Standard Formula for 3 days
Category
Prevention
3
Description
3rd group: enteral nutrition via Bolus infusion every 4 hours with 400 ml volume of Standard Formula for 3 days