Protocol summary

Study aim
Comparison the effect of two methods of NG feeding, monitoring and not monitoring residual gastric volume on risk of ventilator-associated pneumonia
Design
Clinical trial with a control group with sample size of 138 people was allocated randomly by random number table in two groups of intervention and control.
Settings and conduct
The study was conducted in ICU of Golestan Hospital of Ahvaz. In the intervention group, NG feeding was performed with gastric secretion measurements and did not measure in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hospitalization in ICU, connected to ventilator and nutrition by NGT/ Exclusion criteria: patients with renal failure; patients with pneumonia history of abdominal surgery; pregnant patients
Intervention groups
Intervention group: patients received NG feeding after the measurement of gastric secretion volume based on international guidelines. Control group: patients received NGT feeding in a routine manner without the volume of residual gastric secretion measurement.
Main outcome variables
pneumonia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170118032029N3
Registration date: 2018-05-20, 1397/02/30
Registration timing: prospective

Last update: 2018-05-20, 1397/02/30
Update count: 0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8319
Email address
khalafi-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two nasogastric feeding methods, monitoring and not monitoring residual gastric volume on risk of ventilator-associated pneumonia
Public title
Effect of monitoring residual gastric volume on pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in ICU Connected to ventilator Nutrition by NGT
Exclusion criteria:
Patients with renal failure Patients with pneumonia History of abdominal surgery Pregnant patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using random number table. The first sample obtained from table was allocated in the intervention group and the next sample in the control group. This method continued until the end of the sampling.
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.AJUMS.REC.1396.945

Health conditions studied

1

Description of health condition studied
Pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified

Primary outcomes

1

Description
Pneumonia
Timepoint
Measuring the incidence of pneumonia in patients on days 3 and 5 after starting NG feeding
Method of measurement
modified Clinical Pulmonary Infection Score (mCPIS)

Secondary outcomes

empty

Intervention groups

1

Description
Patients in the intervention group received NG feeding after the measurement of gastric secretion volume based on international guidelines.
Category
Prevention

2

Description
Control group: patients received NGT feeding in a routine manner without the volume of residual gastric secretion measurement.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Maedeh Barkhordari
Street address
Golestan Blv, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3337 5485
Email
m.barkhordari1393@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Street address
Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3337 4598
Email
m.barkhordari1393@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3338 4754
Email
Jahanisimin50@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Simin Jahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3338 7451
Email
Jahanisimin50@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maedeh Barkhordari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan Blv, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3338 7547
Email
m.barkhordari1393@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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