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The effect of Infection Control Guidelines implementation on incidence of Ventilator-Associated Pneumonia in hospitalized patients in intensive care unit

Protocol summary

Study aim
determine the effect of infection control guidelines on the incidence of Ventilator Associated Pneumonia (VAP) in patients admitted to the Intensive Care Unit (ICU).
Design
this study is a clinical trial, and in this study non-randomized purposive sampling method was utilized and subjects were divided into two groups of control and intervention.That the VAP prevention guideline is being implemented in intervention group and those guidelines do not apply to them are considered as the control group.
Settings and conduct
This study was conducted to prevent ventilator-associated pneumonia in the form of evidence-based guideline for controlling infection in patients under mechanical ventilation admitted in Intensive Care Unit of Imam Khomeini and Golestan hospitals in Ahvaz city between June 2018 and September 2018 with a sample size of 130 patients and For 5 days, the intervention group includes 65 patients and the control group is 65 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: did not have pneumonia before admission, Tracheal intubation and attachment to ventilator. Exclusion criteria: Length of hospitalization is more than 20 days, below 18 years age
Intervention groups
semi recumbent position,use of standard bed in ICU, change of suction equipment, use of close suction system, oral intubation technique, use of (HME) filter, ventilator circuit change, use of chlorhexidine gluconate mouthwash, subglottic secretion suction, set of Cuff pressure in (ET) tubes in the range of 20–30 cm H2O, elevation the head of the bed at 30 to 45 degrees, during and after gavage. Routine care is performed in the control group and researcher does not intervene.
Main outcome variables
incidence of ventilator associated pneumonia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180709040402N1
Registration date: 2018-09-28, 1397/07/06
Registration timing: retrospective

Last update: 2018-09-28, 1397/07/06
Update count: 0
Registration date
2018-09-28, 1397/07/06
Registrant information
Name
Ali Safavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 9012
Email address
safavi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-23, 1397/04/02
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Infection Control Guidelines implementation on incidence of Ventilator-Associated Pneumonia in hospitalized patients in intensive care unit
Public title
The Effect of Infection Control Guidelines on Incidence of Ventilator-associated Pneumonia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the intensive care unit. Absence of pneumonia before entering the study. Non-Cystic Fibrosis Patients, Pleural Empyema, acquired pneumonia from the community and Neutropenia. did not have aspiration before admission Length of hospitalization is less than 20 days Endotracheal intubation and connected to ventilator
Exclusion criteria:
Extropulmonary infection Symptoms occur less than 48 hours after mechanical ventilation Patients with incomplete file and clinical information
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Not 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
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
No.Golestan, Esfand St, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-06-08, 1397/03/18
Ethics committee reference number
IR.AJUMS.REC.1397.202

Health conditions studied

1

Description of health condition studied
Ventilator-associated Pneumonia (VAP)
ICD-10 code
J17
ICD-10 code description
Ventilator-associated Pneumonia (VAP)

Primary outcomes

1

Description
incidence of ventilator associated pneumonia
Timepoint
Before and after the intervention
Method of measurement
Use of modified Clinical Pulmonary Infection Score (mCPIS)

Secondary outcomes

1

Description
the amount of antibiotic use
Timepoint
before and after the intervention
Method of measurement
taking daily dose

Intervention groups

1

Description
1. semi recumbent position. 2. use of standard bed in ICU. 3. change of suction equipment (Catheter and tube). 4. use of close suction system. 5. oral intubation technique. 6. chest physiotherapy. 7. use of Heat and Moisture Exchanger (HME) filter. 8. ventilator circuit change. 9. hand washing. 10. Deep Venous Thrombosis prophylaxis. 11.peptic ulcer prophylaxis. 12. use of chlorhexidine gluconate (0.2 or 0.12 percent) mouthwash. 13. subglottic secretion suction. 14. set of Cuff pressure in endotracheal (ET) tubes in the range of 20–30 cm H2O. 15. elevation the head of the bed at 30 to 45 degrees, during and after gavage.
Category
Prevention

2

Description
Routine care is performed in the control group and researcher does not intervene.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals of Imam Khomeini and Golestan
Full name of responsible person
Safavi Ali
Street address
Golestan Hospital,Golestan- the 24-meter stree and between the beach boulevard,Martyrdom Square
City
Ahvaz
Province
Khouzestan
Postal code
-61357-15794
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
Safavi.a@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
Ground floor,University of Jundishapur University of Medical Sciences, Assistant Professor of Research and Technology Development, University City
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
Safavi.a@ajums.ac.ir
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
Safavi Ali
Position
student Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Safavi Karim home, 3Shahed Alley ,15 South Khordad
City
Abdanan
Province
Ilam
Postal code
6971664145
Phone
+98 84 3362 3105
Email
Safavi.a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asadi Zakir Marzieh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz, Jundishapur University of Medical Sciences,University of Ahvaz, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
marziyehasadizaker@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Safavi Ali
Position
intensive care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University of Ahvaz, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Fax
+98 61 3336 1544
Email
Safavi.a@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study data can be shared after coding
When the data will become available and for how long
Start accessing the data three months after the publication of the article
To whom data/document is available
Academic and academic institutions
Under which criteria data/document could be used
Citation to the results of the study, comparison with other studies is permitted. And any copying of results and data forms is impermissible.
From where data/document is obtainable
Nursing and Midwifery Library, Faculty of Nursing, Jondishapoor University of Medical Sciences, Ahvaz, Iran. Safavi Ali Project Executive. 09188415182 ،Safaviali999@yahoo.com
What processes are involved for a request to access data/document
Three months after the publication of the article, dated 2019/04/02, emails or telephone data files will be available.
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