Comparison of the effect of two brushing methods with Chlorhexidine mouthwash and Matricaria (Chamomile) mouthwash on ventilator-induced pneumonia (VAP) in patients admitted to intensive care unit
Determining the effect of two methods of brushing with chlorhexidine mouthwash and matrix mouthwash on the incidence of ventilator-induced pneumonia (VAP) in hospitalized patients in the intensive care unit
Design
A three-arm, parallel-group, triple-blinded randomized clinical trial with a control group
Settings and conduct
Eighty eligible patients admitted to the traumatic intensive care unit of Imam Reza Hospital and Valiasr in 2020 selected by convenience sampling method and allocated to one control and two intervention groups Simple randomization. All patients were examined for oral mucosal lesions and dental plaque before intervention and on the 2nd and 5th days after intervention. The study is triple-blinded where the patients, care-providers, and data analysts are not aware of the intervention. Patients in spine position, and if applicable, the head in a 30-degree gradient and the face in a lateral direction. The mouth, gums, tongue, pharynx, and teeth are brushed with a soft brush before intervention. Mouthwashes applied on a daily basis, every 12 hours, for 5 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent provided by the patient or guardian for participation Age between 15 and 65 years Less than 6 hours passed from the patient's admission in the intensive care unit Having an oral tube Having at least 12 natural teeth and not having more than 6 dentures.Exclusion criteria:Diabetes Immune system disorders Traumatic oral injuries Taking anti-coagulant drugs
Intervention groups
There are tow 40-member groups. In the control group, 0.2 percent chlorhexidine gluconate mouthwash will be used. In the intervention group, Matricaria chymomilla extract at a concentration of 10 percent used.
Main outcome variables
Incidence of pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190530043773N2
Registration date:2020-09-08, 1399/06/18
Registration timing:retrospective
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
rasool solaimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3242 4948
Email address
rasoul.soleimani@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two brushing methods with Chlorhexidine mouthwash and Matricaria (Chamomile) mouthwash on ventilator-induced pneumonia (VAP) in patients admitted to intensive care unit
Public title
Comparison of the effect of two methods of brushing with chlorhexidine and Matrica (Chamomile) mouthwash on the incidence of Ventilator-Associated Pneumonia (VAP)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient or guardian consent
Severe oral and maxillofacial injury
Endotracheal tube
Not taking antibiotics before and during hospitalization
Lack of immune system disorder
Lack of ulcers, infection and oral trauma
Exclusion criteria:
Diabetes
Immune system disorders
Traumatic oral injuries
Taking anti-coagulant drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were selected by convenience sampling method and randomly assigned to one of the two intervention groups A (chamomile) and group B (chlorhexidine). The card number was marked with the letters A and B and was written on card A of the chamomile intervention group and on card B of the control group of chlorhexidine. The researcher was asked to remove one of the cards, without knowing which group the patient was in, so the samples were divided into two groups to complete the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors were not informed about how to participate in the blinding process
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
Zabol, Shahid Rajaei St., Vice Chancellor of Zabul University of Medical Sciences
Intervention group (Matricaria chamomilla): Matricaria chamomilla extract at a concentration of 10 percent (made by Adonis Gol Darou Company) administered three times daily with a volume of 10 milliliters for 5 days.
Category
Prevention
2
Description
Control group: (Chlorhexidine gluconate): The control group patients used 0.2 percent chlorhexidine gluconate mouthwash three times daily with a volume of 10 milliliters for 5 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Valiasr Hospital
Full name of responsible person
RasoolSolaimaniMighadam
Street address
Taleghani Street and Ayatollah Ghaffari Street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9718884554
Phone
+98 54 3229 5115
Email
amirhospital@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Khadijeh Rezaei Kikhaei
Street address
Shahid Rajaei Street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Rasool Soleimani Moghaddam
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
rasool.solaimani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Mahin Naderifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ferdowsi street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
graduatezabol@zbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Rasool Soleimani Moghadam
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ferdowsi street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
rasool.solaimani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifing people
When the data will become available and for how long
9 months after publishing the results
To whom data/document is available
Study data will only be available to researchers working in universities and academic institutions
Under which criteria data/document could be used
Only tests performed on study data
From where data/document is obtainable
To receive the data, they can only send their application to the email address of the person responsible for the study. rasool.solaimani@yahoo.com
What processes are involved for a request to access data/document
After reviewing the code of ethics of the requesting inquiry committee and the approval date and the applicant's university identification document