Protocol summary

Summary
Comparison of two methods of feeding tubes through periodic and continuous flow methods, in terms of achieving the calorie goal and its complications in patients hospitalized in ICU wards. Nutritional support of patients under critical conditions and attention to the caloric requirements in order to reduce the fat, protein metabolism and malnutrition, is one of the aspects of caring patients under critical conditions. The frequency of gastrointestinal complications and cut off food in those patients is high. The purpose of this study is Comparison of two methods of feeding tubes through periodic and continuous flow methods, in terms of achieving the caloric goal, calorie intake and its complications in patients hospitalized in ICU wards. Design: After getting permission from the head Employee of Namazi Hospital this intervention study was carried out in intensive units. Methods: After getting the consent form, the form of a clinical trial was conducted on 60 patients hospitalized in the intensive care unit. Inclusion criteria: patients Over 18 years old; disable of getting food through mouth; feeding through a tube for at least 3 days ; using a standard formula. Exclusion criteria of study: active gastrointestinal bleeding; volunteers to receive a specific type of formula; use of gasterestomy tubes; known disorders in absorbing food and having a history of surgery to remove part of the digestive organs, Impossible to bring up the bed above 30 degree, such as spinal cord injuries. Patients were randomly classified into two groups by random numbers table, in case group, the patients were fed continuously and in control group, the patients were fed intermittently. Data on complications and time required to reach caloric goal and intake calorie, were collected in a checklist for a 7-day period. It was then analyzed with Chi-score and t-student tests. First Main outcome: Determine the time required to achieve the target calories, calorie intake and incidence of cases of food intolerance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109287655N1
Registration date: 2011-10-09, 1390/07/17
Registration timing: na

Last update:
Update count: 0
Registration date
2011-10-09, 1390/07/17
Registrant information
Name
Somayeh Zahraei Fard
Name of organization / entity
Ahvaz university of medical science, nursing university
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 2538
Email address
zahraeefard@ajums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research,Shiraz and Ahvaz University of Medical Sciences
Expected recruitment start date
2011-11-16, 1390/08/25
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of feeding tubes through periodic and continuous flow methods, to achieve the caloric goal and its complications in patients hospitalized in ICU wards
Public title
Comparison of two methods of feeding tubes through periodic and continuous flow methods, to achieve the caloric goal and its complications in patients hospitalized in ICU wards
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Older than 18 years; the ability to receive food by mouth; fed through a tube at least 3 days ; using a standard formula. Exclusion criteria of study: active gastrointestinal bleeding; candidate receiving a specific type of formula; use of gasterestomyl tubes ;known problems in absorbing food and having a history of surgery to remove part of the digestive organs.; Impossible to bring up the bed, such as spinal cord injuries
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Jondishapoor- Ahvaz university of medical science ethics committee
Street address
Ahvaz university of medical science, Golestam street, Ahvaz
City
Ahvaz
Postal code
Approval date
2011-05-21, 1390/02/31
Ethics committee reference number
ETH-176

Health conditions studied

1

Description of health condition studied
"nutrition status"
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Time to achieve caloric
Timepoint
During 7 days
Method of measurement
Per day inserted in check list

2

Description
Calories found
Timepoint
During 7 days
Method of measurement
K cal inserted in check list

3

Description
Food intolerance
Timepoint
During 7 days
Method of measurement
cc inserted in check list

Secondary outcomes

1

Description
Diarrhea and vomiting
Timepoint
During 7 days that study carried out
Method of measurement
yes or no

2

Description
During hospitalization
Timepoint
Till 6 month after intervention
Method of measurement
per day

3

Description
during ICU
Timepoint
Till 6 month after intervention
Method of measurement
per day

Intervention groups

1

Description
pump feeding
Category
Treatment - Other

2

Description
intermittent feeding
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Farid Zand
Street address
Namazee hospital, Zand street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Dr Hatam
Street address
Shiraz university of medical science, Zand street, Fars,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shiraz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Ahvaz university of medical science, Golestan street, Ahvaz
City
Ahavaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz university of medical science
Full name of responsible person
Sedighe Fayazi
Position
master of nursing
Other areas of specialty/work
Street address
Ahvaz university medical science, nursing university, Golestan street, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8302
Fax
+98 61 1373 8302
Email
Sadighe_fa@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Farid Zand
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shiraz university of medical science, Zand street, Shiraz
City
Shiraz
Postal code
1978 - 71345
Phone
+98 71 1612 5473
Fax
+98 71 1612 5473
Email
zandf@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Farid Zand
Position
anesthesiologist
Other areas of specialty/work
Street address
Shiraz university of medical science, Zand street, Shiraz
City
Shiraz
Postal code
1978 - 71345
Phone
+98 71 1612 5473
Fax
+98 71 1612 5473
Email
zandf@sums.ac.ir
Web page address
www.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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