Protocol summary
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Study aim
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To examine the effects of mouthwash containing Zataria multiflora essence 2% and chlorhexidin 0.2% on the prevention of ventilator associated pneumonia in patients admitted to intensive care units
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Design
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This is a single blind RCT. A total of 120 patients are selected based on convenience sampling and will be randomly allocated to either the experimental or control group.
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Settings and conduct
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120 patients to be admitted to ICUs are selected based on convenience sampling method and will be randomly allocated to either the experimental or control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients aged 18-65 years
Having a tracheal tube
<12 hours elapsed since ICU admission
Having natural teeth
Exclusion criteria:
Patients with tracheostomy tube
A history of taking antibiotics during the last two weeks
A history of allergy to chlorhexidine and herbal mouthwashes
Reintubation
Severe maxillofacial trauma
Cervical spine immobilization
Pregnant and lactating women
A history of malignancies
A history of head and neck radiotherapy
A history of oral mucositis and periodontal diseases
Patients diagnosed with sepsis
Immune system disorders
Patients with lung diseases
Simultaneously participating in other interventional studies
Patients with COVID-19 in admission
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Intervention groups
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In the experimental group, the nurse will apply 10 CC of Zataria multiflora essence mouthwash 2% twice a day for five consecutive days. This group will also receive the routine mouth care with chlorhexidine 0.2% as the same as the control group. In the control group, the nurse will apply 10 CC of chlorhexidine 0.2% twice a day for five consecutive days.
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Main outcome variables
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Clinical Pulmonary Infection Score
General information
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Reason for update
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Patients will be recruited from two participating hospitals.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210523051370N6
Registration date:
2022-05-21, 1401/02/31
Registration timing:
prospective
Last update:
2022-07-15, 1401/04/24
Update count:
1
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Registration date
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2022-05-21, 1401/02/31
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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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2022-06-05, 1401/03/15
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Expected recruitment end date
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2022-08-23, 1401/06/01
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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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The comparative effects of the mouthwash containing Zataria multiflora essence 2% and chlorhexidine 0.2% on the prevention of ventilator-associated pneumonia in patients admitted to intensive care units
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Public title
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The effect of mouthwash containing Zataria multiflora essence 2% on the prevention of ventilator-associated pneumonia
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients aged 18-65 years
Having a tracheal tube
<12 hours elapsed since ICU admission
Having natural teeth
Exclusion criteria:
Patients with tracheostomy tube
A history of taking antibiotics during the last two weeks
A history of allergy to chlorhexidine and herbal mouthwashes
Reintubation
Severe maxillofacial trauma
Cervical spine immobilization
Pregnant and lactating women
A history of malignancy and cancer
A history of head and neck radiotherapy
A history of oral mucositis and periodontal diseases
Patients diagnosed with sepsis
Patients with immune system disorders
Patients with lung diseases (including pneumonia, asthma, and allergic rhinitis)
Simultaneously participating in other interventional studies
Patients with COVID-19 in admission
Withdrawal criteria: patient death; patients transferred to the ward or other hospitals; reintubation; side effects associated with the use of either mouthwash; oral mucositis and periodontal diseases; sepsis; unwillingness to continue participation in the study; eligibility criteria violated
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Age
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From 18 years old to 65 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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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A total of 120 eligible patients are selected based on convenience sampling and will then be randomly allocated to either the experimental (A) or control group (B) using permuted block randomization. When the block size is four, there are six possible sequences of letter placement (i.e., AABB1-ABBA2-BABA3-BBAA4-BABA5-ABAB6). Using Random Allocation Software 2.0, one of the numbers from one to six is randomly selected thirty times. Each number determines four modes of placement in a block. To ensure the concealment of the sequence of enrolment, we will use the sequentially numbered, opaque sealed envelopes (undertaken by a person unaware of the study objectives and group allocations). Each envelop will contain the group assignment for four patients. The assessor will be blind to treatment allocation.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To ensure the concealment of the sequence of enrolment, we will use the sequentially numbered, opaque sealed envelopes (undertaken by a person unaware of the study objectives and group allocations).
The outcome assessor will also be blind to the random assignment of patients to the groups.
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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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We will only take chest X-rays (CXR) for patients suspected of having pneumonia. An assessor with intensive care subspecialty will interpret the CXRs. Mouthwash (chlorhexidine 0.2% for the control group; chlorhexidine 0.2% + Zataria multiflora essence mouthwash 2% for the experimental group) will be administered twice a day (every 12 hours) for five consecutive days. The assessor will check and record the Clinical Pulmonary Infection Score (CPIS) of all patients on the first, third, and fifth days. The nurse who applies the mouthwash checks the patient's oral condition.
Ethics committees
1
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Ethics committee
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Approval date
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2022-03-30, 1401/01/10
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Ethics committee reference number
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IR.MAZUMS..REC.1401.11695
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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ventilator-associated pneumonia
Primary outcomes
1
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Description
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Clinical Pulmonary Infection Score
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Timepoint
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Clinical Pulmonary Infection Score on first, third and fifth days of mouthwash use
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Method of measurement
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Pulmonary of Infection Survey Questionnaire
Intervention groups
1
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Description
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Intervention group: The patient is assessed for pneumonia using the Clinical Pulmonary Infection Score (CPIS) before the mouthwash is administered. All the tooth surfaces and gum are cleaned using a soft bristled toothbrush and toothpaste for 2 minutes. The teeth and mouth are then cleaned with 5 CC of 0.9% normal saline and oral suction is simultaneously performed for 30 seconds. Chlorhexidine 0.2 (10 cc) is then used to rinse the mouth for one minute twice a day. Thereafter oral suction is done for 30 seconds. Finally, the mouthwash containing Zataria multiflora essence 2% (10 cc) will be applied twice a day for one minute and oral suction is then performed for 30 seconds.
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Category
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Prevention
2
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Description
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Control group: The nurse will apply 10 CC of chlorhexidine 0.2% twice a day for five consecutive 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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Mazandaran 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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All data will be kept confidential
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not 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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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable