Protocol summary
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Study aim
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Determination and comparison of the effects of three oral care programs on oropharyngeal complications and the Occurrence of ventilator associated pneumonia in patients undergoing mechanical ventilation
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Design
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All hospitalized patients with inclusion criteria will be selected and then divided into one of three groups using the statistical software; the study will have two intervention groups and one quasi-intervention group with parallel groups.
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Settings and conduct
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A clinical trial study on prophylaxis is conducted in Isfahan University of Medical Sciences Hospital without blinding
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Participants/Inclusion and exclusion criteria
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patient will have an endotracheal tube; Do not have mucosal inflammation or severe trauma to the mouth; Do not have Chronic Disease and Immune Deficiency; Have teeth; Do not have reentubation; Be the first day of patient intubation; No tracheostomy during the study; no apparent aspiration; at least platelet 40,000; at least INR 2; no transfer or discharge prior to day 7; no pneumonia within 48 hours of study
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Intervention groups
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The three intervention groups included: the first group taking oral care with chlorhexidine solution 0.2% and swab every 12 hours; the second group brushing with chlorhexidine 0.2% every 12 hours; the third group brushing every 6 hours, twice with chlorhexidine 0.2% and twice with normal saline; 12 hours interval; in all three groups oral suctioning, oral cavity moisturizing and lipsticking will be performed every 4 hours
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Main outcome variables
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pneumonia; oropharyngeal complications; oral care
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191012045066N1
Registration date:
2019-11-07, 1398/08/16
Registration timing:
registered_while_recruiting
Last update:
2019-11-25, 1398/09/04
Update count:
1
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Registration date
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2019-11-07, 1398/08/16
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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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2019-10-23, 1398/08/01
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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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Evaluation and comparison of the effects of three oral care programs on oropharyngeal complications and the Occurrence of ventilator associated pneumonia in patients undergoing mechanical ventilation
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Public title
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The effects of oral care program on oropharyngeal complications and the Occurrence 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:
Patient will have an endotracheal tube
Do not have mucosal inflammation or severe trauma to the mouth
Do not have Chronic Disease and Immune Deficiency
Have teeth
Do not have reentubation
Be the first day of patient intubation
Exclusion criteria:
Insertion a tracheostomy for the patient during the study
The obvious aspiration
Reduce platelet count to less than 40000
Increase INR to more than 2
Transfer or discharge the patient to another ward before the seventh day
Diagnose pneumonia within the first 48 hours after mechanical ventilation is started
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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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No information
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initially, patients with inclusion criteria will be selected one by one. Then, the variables defined for the software, including their age, sex, diagnosis, and chip tube number, are entered into the online minimap software. Software randomly divides patients into one of three groups. Sampling will continue this way until the required number of samples is completed.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-08-26, 1398/06/04
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.333
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
2
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Description of health condition studied
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oropharyngeal complications
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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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Clinical pneumonia infection score
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Timepoint
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Before the intervention, on the fourth and seventh days of the intervention
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Method of measurement
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Modified clinical pneumonia infection score
2
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Description
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Oral Health Score
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Timepoint
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On the second, fourth and seventh days of the intervention
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Method of measurement
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Beck Oral Assessment Scale
3
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Description
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Oral Health Score
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Timepoint
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On the second, fourth and seventh days of the intervention
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Method of measurement
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Mucosal Plaque Score
Intervention groups
1
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Description
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Intervention group: Oral care with swab and chlorhexidine solution 0.2% every 12 hours and equal care between groups (oral cavity moistening and lipsticking every 4 hours and oral suctioning if needed)...
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Category
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Prevention
2
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Description
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Intervention group: Oral care with toothbrush and chlorhexidine solution 0.2% every 12 hours and equal care between groups
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Category
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Prevention
3
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Description
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Intervention group: Oral care every 6 hours, twice with toothbrush and 0.2% chlorhexidine solution every 12 hours, twice with toothbrush and normal saline every 12 hours and equal care between groups
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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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Esfahan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available