Comparison of the effect of chlorhexidine and Persica mouthwash in the prevention of ventilator associated pneumonia in patients under ventilator admitted to the intensive care unit
Comparison of the effect of chlorhexidine and Persica mouthwash in preventing ventilator associated pneumonia in patients under ventilator
Design
The present study is a single-blind randomized clinical trial.
Settings and conduct
This single-blind clinical trial study will be conducted to compare the effect of chlorhexidine and Persica mouthwash in the prevention of ventilator associated pneumonia in patients on ventilator admitted to the intensive care unit of Allameh Bahloul Gonabadi Hospital in 2023
Participants/Inclusion and exclusion criteria
Inclusion criteria include age over 18 years and under 65 years, no damage to the mouth, jaw, and face, no immunosuppression due to certain drugs or diseases, the patient should be in the first 24 hours of intubation and should wait at least 72 hours for intubation, a clinical score of lung infection less than 6 on arrival, oral health assessment checklist score 10 and less. Exclusion criteria include having cancer and diabetes and chronic obstructive pulmonary disease, have a history of broad-spectrum antibiotic therapy in the last 3 months, performing the cardiopulmonary resuscitation process, and dissatisfaction of him or his companion to participate in the study.
Intervention groups
In the first intervention group, 15 ml of 0.2% chlorhexidine solution and in the second intervention group, 15 drops of Persica solution will be Mouthwash twice a day for 5 days.
Main outcome variables
Positive culture of the endotracheal tube; positive oral culture; type of microorganisms grown
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231122060135N1
Registration date:2024-01-22, 1402/11/02
Registration timing:registered_while_recruiting
Last update:2024-01-22, 1402/11/02
Update count:0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Mostafa Mirzaee fakhrabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5652 3573
Email address
mostafa.m.f9191@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chlorhexidine and Persica mouthwash in the prevention of ventilator associated pneumonia in patients under ventilator admitted to the intensive care unit
Public title
Comparison of the effect of chlorhexidine and Persica mouthwash in the prevention of ventilator associated pneumonia in patients under ventilator
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No damage to the mouth, jaw and face
Oral health assessment checklist score 10 and less
Clinical score of lung infection less than 6 on arrival
The patient should be Undergo airway intubation on the first day
The patient should remain intubated for at least 72 hours
No immunosuppression due to certain drugs or diseases
Exclusion criteria:
Malignancy
Diabetes
Chronic obstructive pulmonary disease
History of broad-spectrum antibiotic therapy in the last 3 months
Dissatisfaction of patient or his/her companion to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, eligible patients will be selected non-randomized, sequential. Then these patients are coded using computer random allocation software, and then the codes are divided into two parts, and each part of the codes will be assigned to a group.
Blinding (investigator's opinion)
Single blinded
Blinding description
To blind the present study solutions will be prepared similarly in volume, shape, and smell and will be coded with labels A and B. Then these solutions will be given daily to a nurse who is completely unaware of the type of mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
Zabol University of Medical Sciences, Shahid Rajaei Street, Zabol؛Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2023-10-29, 1402/08/07
Ethics committee reference number
IR.ZBMU.REC.1402.091
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
Ventilator associated pneumonia will be determined 5 days after the intervention.
Method of measurement
Clinical Pulmonary Infection Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will receive15 ml of pre-prepared solution containing 0.2% chlorhexidine (Iran Najo Pharmaceutical Company) alone 2 times a day for 5 days. This solution is applied to the mouth and lips, gums and inside the cheeks using a swab.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group will receive15 drop of pre-prepared solution containing Persica (pur sina Pharmaceutical Company) alone 2 times a day for 5 days. This solution is applied to the mouth and lips, gums and inside the cheeks using a swab.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bohloul Gonabadi Hospital
Full name of responsible person
Mostafa Mirzaei
Street address
Allameh Bohloul Gonabadi Hospital.Nurse Boulevard.Saadi street.Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691637838
Phone
+98 51 5723 6832
Email
MOSTAFA.M.F9191@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Khadijeh Rezaie Keikhaie
Street address
Research and Technology Deputy,1st Floor, Zabol University of Medical Sciences Educational Complex, Shahid Rajaei St., Zabol,Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
rezaie.azar@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Mostafa Mirzaei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zabol University of Medical Sciences, Shahid Rajaei Street, Zabol؛Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
MOSTAFA.M.F9191@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mostafa Mirzaei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zabol University of Medical Sciences, Shahid Rajaei Street, Zabol؛Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
MOSTAFA.M.F9191@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mostafa Mirzaei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zabol University of Medical Sciences, Shahid Rajaei Street, Zabol؛Iran
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2120
Email
MOSTAFA.M.F9191@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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