This study is a triple group crossover clinical trail which is done on 90 patients hospitalized in intensive care units of educational hospitals affiliated to kermanshah University of Medical Science. Patients who have the inclusion criteria to enter in to this study, are placed in 3 groups randomly. Patients who are in the first group, in the first gavage are placed in the supine position, the next gavage in the right lateral position and in the third gavage in the left lateral position. Then patients of the second group in the first gavage are placed in the right lateral position, the next gavage in the supine position, and in the third gavage in the left lateral position. Patients of the third group in the first gavage are placed in the left lateral position, the next gavage in the supine position and in the third gavage in the right lateral position. Before each feeding, first researcher measures the patients gastric residual volumes with standard gavage syringe and registers them. Then he feeds patients through nasal gastric tube and keeps them in the same positions for 3 hours. Tow and three hours after keeping them in that very position he measures the gastric residual volumes of the patients again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042617267N4
Registration date:2014-05-23, 1393/03/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Jahangir Rezaie
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 2102
Email address
j-rezaie@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of body position on gastric residual volume in patients with mechanical ventilation hospitalized in intensive care unit
Public title
The effect of body position on gastric residual volume
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patient with mechanical ventilation should be equipped 48 hours before intervention; Patient with nasal gastric tube and intestinal nutrition from 48 hours before intervention; Age between 18-65 years; Not pregnant patient; Patients who do not have any changing status limitations; Patients who have G.C.S scores equal to or lees than 7. Exclusion criteria: Using drugs which enhance bowel smoky shape movements during study for patients; Suffering diarrhea; Transfer the patients to the other units; Separation of the patients from mechanical ventilation; Patients death.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2014-02-11, 1392/11/22
Ethics committee reference number
49402
Health conditions studied
1
Description of health condition studied
The relationship between body position with gastric residual volume in hospitalized payients with mechanical ventilation.
ICD-10 code
w87
ICD-10 code description
Gastric contents
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Before, 2 and 3 hours after intervention.
Method of measurement
With standard gavage syringe
Secondary outcomes
empty
Intervention groups
1
Description
In this study, researcher placed the first group of the patients in the first gavage in the supine position, in the next gavage in the right lateral position, and the third gavage in the left lateral position. Meanwhile, before each feeding, first he measures the patients gastric residual volumes with the standard gavage syringe and registers them. Then he feeds them through nasal gastro tube and keeps them in the same position for 3 hours. Two and three hours after keeping them in that very position he measures their gastric residual volumes again.
Category
Treatment - Other
2
Description
In this study, researcher placed the second group of the patients in the first gavage in the right lateral position, in the next gavage in the supine position, and the third gavage in the left lateral position. Meanwhile, before each feeding, first he measures the patients gastric residual volumes with the standard gavage syringe and registers them. Then he feeds them through nasal gastro tube and keeps them in the same position for 3 hours. Two and three hours after keeping them in that very position he measures their gastric residual volumes again.
Category
Treatment - Other
3
Description
In this study, researcher placed the third group of the patients in the first gavage in the left lateral position, in the next gavage in the supine position, and the third gavage in the right lateral position. Meanwhile, before each feeding, first he measures the patients gastric residual volumes with the standard gavage syringe and registers them. Then he feeds them through nasal gastro tube and keeps them in the same position for 3 hours. Two and three hours after keeping them in that very position he measures their gastric residual volumes again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational hospitals affiliated to Kermanshah University of Medical Science, Kermanshah
Full name of responsible person
Houshang Kadivarian
Street address
Basije Streeth, Eslam Abade Gharb, Kermanshah
City
Eslam Abade Gharb
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Vice Research and Technology Affair, No 2 Building, Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Houshang Kadivarian
Position
Student of critical care nursing
Other areas of specialty/work
Street address
Basije Street, Eslam Abade Gharb, Kermanshah
City
Eslam Abade Gharb
Postal code
6761766599
Phone
+98 83 2522 0443
Fax
+98 83 2522 0443
Email
hkadivarian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Houshang Kadivarian
Position
Student of critical care nursing
Other areas of specialty/work
Street address
Basije Street, Eslam Abade Gharb, Kermanshah
City
Eslam Abade Gharb
Postal code
6761766599
Phone
+98 83 2522 0443
Fax
+98 83 2522 0443
Email
hkadivarian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Houshang Kadivarian
Position
Student of critical care nursing
Other areas of specialty/work
Street address
Basije Street, Eslam Abade Gharb, Kermanshah
City
Eslam Abad Gharb
Postal code
6761766599
Phone
+98 83 2522 0443
Fax
+98 83 2522 0443
Email
hkadivarian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)