Effect of Clove extract mouthwash on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical Care Unit
Design
Clinical trial, by using block randomization, the patients enter in intervention or control group, a pilot study including 10 patients from each group, will determine the size of the sample, parallel groups, triple blind.
Settings and conduct
This study is a triple blind randomized clinical trial that is done in the intensive care units of kosar hospital of Semnan. The nurse who performed the mouthwash, patients and the physician evaluating ventilator-associated pneumonia and statistician were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: new patient admitted to the intensive care unit; age over 18 years; patients under mechanical ventilation for more than 48 hours; no aspiration symptoms or pneumonia; no infection with Covid-19; no contraindications to oral care; no contraindication to elevation of head of bed at least 30 degrees; insensitivity to chlorhexidine 0.2%. Exclusion criteria: fever 38.5 and above during the first 24 hours after intubation; positive PCR test (infection of Covid-19); re-intubation more than 3 times; apache II score above 30.
Intervention groups
In the intervention group, mouthwash by 15 ml of clove extract, with concentration 33% from 20% solution, are doing twice a day in 8 am and 4 pm for 5 days. In the control group, mouthwash by 15 ml of Chlorhexidine 0.2% solution, are doing twice a day in 8 am and 4 pm for 5 days.
Main outcome variables
Ventilator-Associated Pneumonia is evaluated with the assessment tool of ventilator-associated pneumonia modified.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110427006318N13
Registration date:2020-10-11, 1399/07/20
Registration timing:prospective
Last update:2020-10-11, 1399/07/20
Update count:0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-26, 1399/08/05
Expected recruitment end date
2021-04-25, 1400/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Clove extract mouthwash on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical care unit
Public title
Effect of Clove extract mouthwash on incidence of Ventilator-Associated Pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
New patient admitted to the intensive care unit
Age over 18 years
Patients under mechanical ventilation for more than 48 hours
No aspiration symptoms or pneumonia
No infection with Covid-19
No contraindications to oral care
No contraindication to elevation of head of bed at least 30 degrees
Insensitivity to chlorhexidine 0.2%
Exclusion criteria:
Fever 38.5 and above during the first 24 hours after intubation
Positive PCR test (infection of Covid-19)
Re-intubation more than 3 times
Apache II score above 30
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample assigned to the groups of the study by permuted blocks randomization. The blocks will be AB or BA. A is the intervention group, B is the control group. After randomly selecting one of the two possible blocks, two consecutive samples are randomly placed in intervention or control group. Blocking is used within gender and age. Regarding to the age, the first patient is randomly placed in the intervention or control group, the next patient with maximum age difference of five years is placed in another group. If the next patient's age difference is more than five years, the patient is randomly placed in another age block. Regarding to the gender, randomization is done separately for men and women. In other words, the first female patient is randomly placed in the intervention or control group and next female patient is placed in another group. For the male patients division is done in the same way.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, mouthwashes will be prepared by the investigator and given blindly to the critical care unit nurse, who performed the mouthwash. Patients are not aware of the type of solution. The physician evaluating Ventilator-Associated Pneumonia and the statistician are blind to the study groups (intervention and control).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical science
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.184
2
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical science
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.184
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia
ICD-10 code
j69.0
ICD-10 code description
Pneumonitis due to food and vomit
Primary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
1th and 5th days
Method of measurement
The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure to inspired oxygen fraction and chest x ray diagnose pneumonia.
Secondary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
1th and 5th days
Method of measurement
The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure to inspired oxygen fraction and chest x ray diagnose pneumonia.
Intervention groups
1
Description
Intervention group: In the intervention group, mouthwash by 15 ml of clove extract, with concentration 33% from 20% solution, prepared from Dr. Jahangir company, are doing twice a day in 8 am and 4 pm for 5 days.
Category
Prevention
2
Description
Control group: In the control group, mouthwash by 15 ml of Chlorhexidine 0.2% solution, prepared from the donyaye behdasht company, are doing twice a day in 8 am and 4 pm for 5 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Monir Nobahar
Street address
Faculty Nursing and Midwifery, Semnan University of Medical Sciences, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data is confidential
Study Protocol
Yes - There is 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
Data is confidential
When the data will become available and for how long
It was possible to publish the paper from the study.
To whom data/document is available
Research group
Under which criteria data/document could be used
After publishing the resulting paper, it can be made available to others in order to use the results of the study.
From where data/document is obtainable
An article published in an valid journal among available journals
What processes are involved for a request to access data/document
The process of publishing an article in the journal