A comparative study of chlorhexidine mouthwash with plant-based mouthwash in the prevention of ventilator-related pneumonia in patients admitted to the intensive care unit
Determining and comparing the effect of chlorhexidine mouthwash with plant-based mouthwash in the prevention of ventilator-related pneumonia in patients admitted to the intensive care unit of Al-Zahra Hospital in 2018-2019
Design
A clinical trial with two intervention groups, with parallel, two-way blind, randomized groups
Settings and conduct
This study was a randomized double-blind clinical trial that was performed in 1397 in the intensive care unit of Al-Zahra Hospital in Isfahan. 80 patients admitted to the intensive care unit were selected to participate in this study if they had entry criteria. In order to observe blindness, the study of patients and the individual who determines the final result of the study (the patient's physician) was not aware of the groups under study and the study was of the double-blind type.
Participants/Inclusion and exclusion criteria
inclusion criteria: age over 18 years, no chip use before entering the intensive care unit
Intervention groups
In the first group, treatment with chlorhexidine is performed. Chlorhexidine gluconate 0.2% of the Shahrdarou-Tehran Pharmaceutical Factory is used for these patients. In the second group, treatment was started with Dineh mouthwash made by Dineh Pharmaceutical Company. Frequency, timing, and method of mouth washing in both groups will be done in the same way and three times a day for 5 days, every eight hours. Was.
Main outcome variables
Duration of hospitalization in the ICU,
Pneumonia,
Oral infections,
Chronic obstructive pulmonary disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047059N1
Registration date:2020-11-09, 1399/08/19
Registration timing:retrospective
Last update:2020-11-09, 1399/08/19
Update count:0
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Yeganeh Fatemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
ygn.ftm1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of chlorhexidine mouthwash with plant-based mouthwash in the prevention of ventilator-related pneumonia in patients admitted to the intensive care unit
Public title
Comparative effect of chlorhexidine mouthwash with plant-based mouthwash in the prevention of pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Requires mechanical ventilation for at least 48 hours
Do not use the chip pipe before entering the intensive care unit
No specific lesions in and around the mouth
Lack of safety defects
Do not take antibiotics before hospitalization
No pregnancy
Lack of allergy to plant compounds
Has natural teeth
Free and informed written consent of the patient's companion or guardian to participate in the study
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simply put, the individual was divided into two groups of 40 by referring to the hospital and the relevant department and using the SPSS statistical software version 23.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, the study of patients and the person who determines the final result of the study (the patient's doctor) will not be aware of the groups under study and the study will be of the blind type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
Street address
Hezar Jarib St. Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.MUI.MED.REC.1399.021
Health conditions studied
1
Description of health condition studied
Ventilate-related pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Ventilator-related pneumonia
Timepoint
At the beginning of the study and 3 weeks after using two mouthwashes
Method of measurement
A microbial infection of the lung that occurs more than 48 hours after mechanical ventilation with a ventilator. Diagnosis of this type of pneumonia is based on the symptoms of pulmonary infection (including: purulent discharge, fever and leukocytosis), bacteriological evidence of pulmonary infection, and evidence of lung infection on specific radiographic images.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, treatment with chlorhexidine is 0.2%. The frequency, timing, and manner of mouth washing in this group will be performed in the same way, three times a day for 5 days, every eight hours. First, a sterile gauze wrap is wrapped around an abscess and then soaked in a mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved.
Category
Treatment - Drugs
2
Description
Intervention group: Dine mouthwash made by Dineh Pharmaceutical Company. In the second group, treatment will begin with a mouthwash. Frequency, timing, and method of mouth washing in both groups will be done in the same way and three times a day for 5 days, every eight hours. First, a sterile gauze wrapped around a tongue blade and then soaked in mouthwash, and like a toothbrush, all areas of the mouth, gums, tongue, throat, and teeth are washed for 6 minutes. The amount of chlorination in each wash is 10 cc and in the case of butter, the consumption of 25-20 drops per half cup of water is dissolved.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital's intensive care unit in Isfahan
Full name of responsible person
Babak Alikiaii
Street address
Hezar Jarib St.-Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
alikiaiib@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Street address
Hezar Jarib St.-Isfahan University of Medical Sciences and Health Services
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
alikiaiib@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Yeganeh Fatemi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib St, Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 5550 0111
Fax
Email
ygn.ftm1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Yeganeh Fatemi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jerib St, Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 5550 0111
Fax
Email
ygn.ftm1994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jerib St, Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
ygn.ftm1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A part of the data such as information about the main consequence
When the data will become available and for how long
Starting access in the fall of 2020
To whom data/document is available
Researchers
Under which criteria data/document could be used
In case of further studies and changes in different doses and materials, the use of documents is allowed.
From where data/document is obtainable
Submit a request by e-mail to the author and provide a title related to the study
What processes are involved for a request to access data/document
The request will be sent by e-mail and the documents will be sent one week after the review.