Protocol summary
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Study aim
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Evaluation and Comparison of the Effects of Chlorhexidine and Ozonated Water Mouthwashes on the Mouth Health and Incidence of VAP in Patients Connected to Mechanical Ventilator in ICU
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Design
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In this study, using the quadruple-block random allocation method, the eligible subjects will be grouped into two groups administered by chlorhexidine and ozonated water mouthwashes (39 subjects in each group)
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Settings and conduct
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The present study will be performed at an ICU of Baghiyyatollah Hospital. the patients will be grouped into either intervention or control group. The intervention will be applied for 5 days, with the mouth health inspection performed every other day, the VAP will be examined without a knowledge of the group to which each subject belongs.
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Participants/Inclusion and exclusion criteria
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Inclusions criteria: Availability of tracheal tube and connecting to the mechanical ventilator within no more than 24 hours from the intubation of the patient and connection to the machine, No oral wounds or injuries, No immunosuppressive diseases, No symptoms of aspiration, No coagulation abnormalities, No dentures, No asthma, No allergy and nose/mouth inflammation, No radiotherapy treatment, No use of antibiotic mouthwash during the past two month, No pregnancy and exclusions criteria: any allergic response or reaction to brushing or any of the mouthwashes is observed, any of the symptoms of the aspiration is observed, symptoms of lung infection are observed, the patient is re-intubated , the patient’s first-order relative(s) refuse to have the study continue, the patient is transferred to another hospital.
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Intervention groups
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The effects of chlorhexidine and 0.2% ozonated water mouthwashes on the mouth health and incidence of VAP will be investigated in intervention and control groups.
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Main outcome variables
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survey of oral health and incidence of ventilator-associated pneumonia
General information
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Reason for update
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Changing the age range of the research participant
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180213038720N2
Registration date:
2019-12-18, 1398/09/27
Registration timing:
registered_while_recruiting
Last update:
2020-05-13, 1399/02/24
Update count:
1
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Registration date
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2019-12-18, 1398/09/27
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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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2019-09-23, 1398/07/01
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Expected recruitment end date
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2020-05-21, 1399/03/01
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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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A survey of the effect of ozonated water mouthwash on oral health and incidence of ventilator-associated pneumonia in patients connected to mechanical ventilation in intensive care units - A randomized clinical trial
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Public title
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A survey of the effect of ozonated water mouthwash on oral health and incidence of ventilator-associated pneumonia in patients connected to mechanical ventilation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Availability of tracheal tube and connecting to the mechanical ventilation machine within no more than 24 hours from the intubation of the patient and connection to the machine.
No oral wounds or injuries
No engagement with immunosuppressive diseases
No record or symptoms of aspiration
No coagulation abnormalities
No dentures
No engagement with the asthma
No allergy and nose/mouth inflammation
No record of radiotherapy treatment
No use of antibiotic mouthwash during the past two months
No pregnancy
NO symptoms of pulmonary infection
Exclusion criteria:
any allergic response to brushing, Toothpaste and any of the mouthwashes
the patient’s first-order relative(s) dissatisfaction with the study.
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Age
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From 15 years old to 85 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is planned to be performed using quadruple-block random allocation method to conduct experiments in two groups using chlorhexidine and ozonated water as mouthwash. The patients will be included in the study and grouped under either of the two groups using SNOSE (Sequentially
numbered, sealed, opaque envelopes) allocation concealment and the designed quadruple blocks by a statistics expert.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For the purpose of this study, the blinding will be performed as follows. Firstly, the resident at the ICU will group each patient under either of the two groups (chlorhexidine and ozonated water) using the designed quadruple blocks by a statistics expert. Next, trained nurses will administer, according to the respective protocol, the patients with the respective mouthwash without even knowing the type of the mouthwash. In the next stage, the researcher will undertake the mouth and teeth health inspection to see whether the ventilator-associated pneumonia (VAP) has occurred without no information on the grouping of the patients. Finally, once collected, the data will be analyzed by the statistics expert with no information about the group to which each patient belongs.
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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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2019-09-02, 1398/06/11
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Ethics committee reference number
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IR.BMSU.REC.1398.146
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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J67.7
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ICD-10 code description
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Air conditioner and humidifier lung
2
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Description of health condition studied
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oral health
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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oral health
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Timepoint
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Every other day
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Method of measurement
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Beck Oral Assessment Scale (BOAS), Mucosal Plaque Score (MPS)
2
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Description
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incidence of ventilator-associated pneumonia
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Clinical Pulmonary Infection Score (CPIS), Cultivation of pharynx
Intervention groups
1
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Description
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Intervention group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the ozonated water solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes.
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Category
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Prevention
2
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Description
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Control group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the chlorhexidine 0.2 solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes.
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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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Bagheiat-allah 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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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Collected data will be given to the individuals or organizations -a raw information- that will be provided with the consent of the participants without any name, address or telephone number, and other items.
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When the data will become available and for how long
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After we have finished the study if data crashed or disposed it will be reachable in a raw information.
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To whom data/document is available
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Just those have a Written request from authoritative research organizations.
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Under which criteria data/document could be used
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If there was need to be called in analysis field you can call 09116470641.
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From where data/document is obtainable
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Mostafa Soodmand, phone number: 09116470641
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What processes are involved for a request to access data/document
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After confirmation the requeste, only raw and unidentifiable information from the mail will be delivered within one week.
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Comments
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If you have any question about this study call these numbers.
09116470641- 09155328439