Evaluation of three methods in prevention Ventilator-Associated
Pneumonia in intensive care unit
Design
This study is clinical trial and double blind. 201 patients in ICU ward in Valiasr hospital in arak city enter this study.We will divide patients in 3 groups.
Settings and conduct
This study is clinical trial and double blind. 201 patients in ICU ward in Valiasr hospital in arak city will enter.We will divide patients in 3 groups by random number table. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All persons with intubation in intensive care unit of Valiasr hospital ,both sexes
Exclusion criteria: Dissatisfied to participate in the study
Intervention groups
Group A: VAP Bundle and personnel hand wash (before each action for the patient) and frequent suction of discharge at least every 6 hours and for every case
Group B: Bundle VAP and personnel regular hand washing procedures (before each intervention for the patient) and oral mucosal cleaning with chlorhexine 0.12 percent for 2 times a day, and at frequent suctioning of the secretions at least every 6 hours and for every case.
Group C: Bundle VAP and personnel hand washing and mouth washing of patients with chlorhexidine 0.12 percent and closed suction every 6 hours and case.
Main outcome variables
Frequency of ventilator-associated pneumonia, duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N116
Registration date:2019-07-13, 1398/04/22
Registration timing:retrospective
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison three methods in prevention Ventilator-Associated Pneumonia in intensive care unit
Public title
Comparison three methods in Pneumonia in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All intubated patients in intensive care units of Valiasr hospital
Both sexes
Exclusion criteria:
No consent to participate in the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
201
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in three groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group1 and the same number of cards for intervention group 2 and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping. Groups A and B and C are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ARAKMU.REC.1396.106
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
after 48 hours
Method of measurement
Phlegm cultures
2
Description
Duration of hospitalization
Timepoint
After intervention
Method of measurement
day
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: VAP Bundle and personnel hand wash (before each action for the patient) and frequent suction of discharge at least every 6 hours and for every case
Category
Prevention
2
Description
Intervention group: Bundle VAP and personnel regular hand washing procedures (before each intervention for the patient) and oral mucosal cleaning with chlorhexine 0/12 percent for 2 times a day, and at frequent suction of discharge at least every 6 hours and for every case
Category
Prevention
3
Description
Intervention group: Bundle VAP and hand washing in personnel and mouth washing of patients with chlorhexidine 0/12 percent and closed suction every 6 hours and case.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Nader Zarinfar
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3645
Fax
+98 86 3222 2003
Email
zarinfar@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street