This study is a double group crossover clinical trial without blinding which is setup on 36 patients hospitalized in intensive care units of Besat hospital in Tehran, Iran. The purpose of this study is assessment the effect of body position on gastric residual volume in patients undergoing mechanical ventilation in intensive care units. Patients, who have the inclusion criteria of research are assigned to group A and group B pseudo randomly. On the first day of study, group A patients, are placed in the semi recumbent position after the first gavage, and in right lateral position after the second gavage with a washout period of 3 hours. Then, patients of group B, are placed in right lateral position after the
first gavage and in semi recumbent position after the second gavage
after 3 hours. Before each feeding, at first researcher measures the patient's gastric residual volume with standard gavage syringe and registers them. Finally, gastric residual volumes are compared in 2 groups in every mentioned position. All Patients feeding will be according to continuous bolus method. Meanwhile, patients apache3 score will be calculated and compared in 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110623446N6
Registration date:2016-05-13, 1395/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
z.farsi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
This research has been funded by vice chancellor grant for research of AJA University of Medical Sciences
Expected recruitment start date
2016-03-15, 1394/12/25
Expected recruitment end date
2016-06-14, 1395/03/25
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 undergoing mechanical ventilation in intensive care units.
Public title
The effect of body position on gastric residual volume
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients, who are hospitalized in medical intensive care units; Age between 18-65 years; Feeding via naso-gastric tube; Patients, who are undergoing invasive mechanical ventilation 48 hours before intervention; Taking no drugs that affect the gastric motility during recent week before intervention; Patients, who do not have acute gastric disorders; Patients, who are not pregnant; Patients, who do not have any limitation or contraindications of body change position.
Exclusion criteria:
Taking drugs that affect gastric motility during the study; Increase the level of conscious and the ability of eating during the study; Change of feeding route; Discharging or transferring of patient from intensive care unit during the study; Weaning of the patient from mechanical ventilation machine.
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Allocate the groups into A and B will be according to pseudo randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemadzadeh St, Fatemi St, Tehran
City
Tehran
Postal code
4813718414
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.AJAUMS.REC.1394.48
Health conditions studied
1
Description of health condition studied
relation between body position and gastric residual volume in patients undergoing mechanical ventilation in intensive care units
ICD-10 code
w78
ICD-10 code description
gastric content
Primary outcomes
1
Description
Gastric residual volume
Timepoint
Before 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 patients in group A in semi recumbent position after the first gavage, and in right lateral position after next gavage for 3 hours. Meanwhile, before each feeding, first she measures the patient gastric residual volume with standard gavage syringe and registers them.
Category
Other
2
Description
In this study, researcher placed the patients in group B in right lateral position after the first gavage and in semi recumbent position after next gavage for 3 hours. Meanwhile, before each feeding, first she measures the patients gastric residual volume with standard gavage syringe and registers them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital of Tehran
Full name of responsible person
Masoumeh kamali kalati
Street address
Hejrat street, Takhti Y Track, Afsariye highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, AJA University of Medical Sciences
Full name of responsible person
Dr. Kamran Azma
Street address
AJA University of Medical Sciences, Etemadzadeh St, Fatemi St, Tehran
City
Tehran
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, AJA 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
AJA University of Medical Sciences
Full name of responsible person
Shahla Aliyari
Position
PhD/ Research Manager
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
4813718415
Phone
+98 21 7750 0404
Fax
Email
z.farsi@ajaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Zahra Farsi
Position
Nursing PhD
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
4813818415
Phone
+98 21 7750 0404
Fax
Email
z.farsi@ajaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Masoumeh kamali kalati
Position
MSc/nurse
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
masoume_kamali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)