Comparison of The Effect of Two Methods Mouth Wash (Chlorhexidine and Chlorhexidine Combined with Hydrogen Peroxide Solution) on Frequency of Oral Plaques and Ventilator-Associated Pneumonia in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit of Imam Khomeini Educational Center, Urmia. 2017-18
The aim of this study was to determine the effect of applying two Methods Mouth Wash (Chlorhexidine and Chlorhexidine Combined with Hydrogen Peroxide Solution) on Frequency of Oral Plaques and Ventilator-Associated Pneumonia in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit.
Design
A randomized clinical trial, pre test-post-test, with control group.
Settings and conduct
The study is a randomized clinical trial with a parallel design on two groups of patients in the intensive care unit of Imam Khomeini Hospital in Urmia, where 98 patients with inclusion criteria were randomly assigned into two groups A and B.Intervention in group A was oral care with chlorhexidine mouthwash (0.2%) and in group B (0.2% chlorhexidine mouthwash with 1.5% hydrogen peroxide solution).
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study: 1) Age 18 to 65 years 2) Less than 48 hours have passed since the patient was admitted to the intensive care unit 3) No use of antibiotics before admission 4) No chronic diseases 5) No immune system disorder 6) No damage by endotracheal intubation or airway
Intervention groups
In group A mouth washing was performed with oral chlorhexidine 0.2% by the researcher and his trained assistant.
In Group B, in addition to doing the above, 10 min after completing the work, 10 mL of hydrogen peroxide solution was poured into the Steel kidney tray, and the cotton swab was immersed in a 1.5% oxygenate solution and The oral cavity, tongue, and teeth were washed for 2 minutes, and at the end, a deep throat mouth suction was taken.
Main outcome variables
Number of oral Plaques;
Ventilator-Associated Pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038053N1
Registration date:2018-09-09, 1397/06/18
Registration timing:retrospective
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Mohammad Jabbari ghanati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
jabbari.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2018-03-10, 1396/12/19
Trial completion date
2018-08-12, 1397/05/21
Scientific title
Comparison of The Effect of Two Methods Mouth Wash (Chlorhexidine and Chlorhexidine Combined with Hydrogen Peroxide Solution) on Frequency of Oral Plaques and Ventilator-Associated Pneumonia in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit of Imam Khomeini Educational Center, Urmia. 2017-18
Public title
Effect of Two Methods Mouth Wash (Chlorhexidine and Chlorhexidine Combined with Hydrogen Peroxide Solution) on Frequency of Oral Plaques and Ventilator-Associated Pneumonia in Patients Undergoing Mechanical Ventilation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Less than 48 hours have passed since the patient was admitted to the intensive care unit.
The lack of a specific lesion of mouth and around it by using the Beck Criterion
Exclusion criteria:
Antibiotics use before admission
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
98
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples were placed through coin tossing in one of the control and intervention groups.
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 Urmia University of Medical Sciences
Street address
Vice-chancellor for research of Urmia University of Medical Sciences, Resalat Blvd
Intervention group: Mouthwash was performed in group A with oral chlorhexidine 0.2% by the researcher and his trained assistant.
Category
Prevention
2
Description
Intervention group: In Group B, in addition to doing the above, 10 min after completing the work, 10 mL of hydrogen peroxide solution was poured into the Steel kidney tray, and the cotton swab was immersed in a 1.5% oxygenate solution and oral cavity, tongue, and teeth were washed for 2 minutes, and at the end of mouthwash, a deep throat mouth suction was taken.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Urmia
Full name of responsible person
Mohammad Jabbari Ghanati
Street address
No.13 , Kaboodan, boostan, Saadi 1Ave
City
Urmia
Province
West Azarbaijan
Postal code
27555899636
Phone
+98 44 3328 4619
Email
jabbari.m@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Jabbari Ghanati
Street address
No.13 , Kaboodan, boostan, Saadi 1Ave
City
Urmia
Province
West Azarbaijan
Postal code
2755589774
Phone
+98 44 3368 4619
Email
jabbari.m@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Jabbari Ghanati
Position
clinical supervisor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13 , Kaboodan, boostan, Saadi 1Ave
City
Urmia
Province
West Azarbaijan
Postal code
2755589696
Phone
+98 44 3368 4619
Email
jabbari.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Jabbari ghanati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Khomeini Hospital.,Ershad Blvd
City
Urmia
Province
West Azarbaijan
Postal code
2755599665
Phone
+98 44 3346 9931
Fax
+98 44 3346 9939
Email
m.jabbari647@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Jabbari Ghanati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam Khomeini Hospital.,Ershad Blvd
City
Urmia
Province
West Azarbaijan
Postal code
2755599665
Phone
+98 44 3346 9931
Fax
+98 44 3346 9939
Email
m.jabbari647@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available