Protocol summary
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Study aim
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Determine the effect of Propolis mouthwash on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical care units.
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Design
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This is a double blind randomized controlled clinical trial with a parallel group design.
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Settings and conduct
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This study is done in ICU Imam Hussein (AS) and Bahar hospitals in Shahroud. Intervention in both groups is the same and randomize. Patients of experimental and control groups receive daily twice Propolis and Chlorhexidine mouthwash, respectively. Patients are mouthwash for 7 days and ventilator-associated pneumonia assessed in 1th; 3th; 5th and 7th days. Nurse and the data analyst are blinded to the allocation status.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients 18-75 years old; Under mechanical ventilation for more than 48 hours; Glasgow Coma scale between 6-11; Feeding with gastric tube; No contraindications to oral care; Propolis insensitivity. Exclusion criteria: Tracheotomy; Jaw and facial trauma; Weakness of the immune system.
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Intervention groups
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In the intervention group, mouthwash by using Propolis solution, each containing 3 mg of propolis in 1 ml, are doing twice a day in 8 am and 4 pm for 7 days. In the control group, mouthwash using Chlorhexidine 0.2% solution, twice a day in 8 am and 4 pm for 7 days.
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Main outcome variables
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Ventilator-Associated Pneumonia
General information
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Reason for update
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Student problems related to pregnancy and childbirth, having a baby, have led to delays in the sampling process.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110427006318N12
Registration date:
2019-04-02, 1398/01/13
Registration timing:
registered_while_recruiting
Last update:
2022-04-18, 1401/01/29
Update count:
1
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Registration date
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2019-04-02, 1398/01/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-04, 1397/11/15
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Expected recruitment end date
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2023-03-11, 1401/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Propolis mouthwash on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit
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Public title
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Effect of Propolis mouthwash on incidence of Pneumonia in hospitalized patient in critical care unit
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients 18-75 years old
Under mechanical ventilation for more than 48 hours
Glasgow Coma scale between 6-11
Feeding with gastric tube
No contraindications to oral care
Propolis insensitivity
Exclusion criteria:
Tracheotomy
Jaw and facial trauma
Weakness of the immune system
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The research sample assigned to the groups of the study by permuted blocks randomization. In order to establish the number of samples assigned to each group (intervention and control), a random method with 4 blocks is used, so that each block has an equal number of each group, and the research sample assigned to the groups of the study by blocks randomization. Also blocking is used within age, sex and mode of the mechanical ventilation device. According to the age, sex and mode of mechanical ventilation variables are influence factors to the ventilator associated pneumonia; patients are selected and blocked that they are similar to another age (± 5 years, maximum difference 10 years), sex and mode of mechanical ventilation.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The propolis mouthwash is used in intervention group and the chlorhexidine mouthwash is used in the control group. Propolis mouthwash (A) and chlorhexidine mouthwash (B) defined and blind available to the nurse. Also the data analyst is blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-18, 1397/09/27
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Ethics committee reference number
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IR.SEMUMS.REC.1397.208
Health conditions studied
1
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Description of health condition studied
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Ventilator-Associated Pneumonia
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ICD-10 code
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J95.851
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ICD-10 code description
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J95.851 Postprocedural respiratory disorders, not elsewhere classified
Primary outcomes
1
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Description
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Ventilator-Associated Pneumonia
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Timepoint
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1th; 3th; 5th and 7th days
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Method of measurement
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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 (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia.
Intervention groups
1
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Description
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Intervention group: In the intervention group, mouthwash by using Propolis solution, each containing 3 mg of propolis in 1 ml, are doing twice a day in 8 am and 4 pm for 7 days.
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Category
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Prevention
2
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Description
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Control group: In the control group, mouthwash using Chlorhexidine 0.2% solution, twice a day in 8 am and 4 pm for 7 days.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Data is confidential
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Data is confidential
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When the data will become available and for how long
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It was possible to publish the paper from the study.
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To whom data/document is available
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Research group
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Under which criteria data/document could be used
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After publishing the resulting paper, it can be made available to others
in order to use the results of the study.
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From where data/document is obtainable
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An article published in an valid journal among available journals
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What processes are involved for a request to access data/document
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The process of publishing an article in the journal
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Comments
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