Comparison of the effect of Chlorhexidine mouthwash with Irsha Mouth–Wash Drop on probable ventilator-associated pneumonia in intensive care unit
Design
This study is a double-blind randomized clinical trial study with parallel groups. 80 intubated patients undergoing mechanical ventilation will be divided into two groups using Random Allocation Software. Intervention group 1 includes (washing of mouth and teeth with 10 cc chlorhexidine 0.2% three times of day until 5 days) and intervention group 2 (washing of mouth and teeth with 20-25 drops irsha 0.2% three times of day until 5 days).
Settings and conduct
This study was carried out in Al-Zahra hospital in Isfahan during 2019 to 2020. A total of 80 patients undergoing mechanical ventilation are enrolled in the study according to inclusion and exclusion criteria and are divided into two groups of chlorhexidine and irsha by random allocation software. Patients, drug prescriber, data collector, and data analyzer were not aware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, requires mechanical ventilation for at least 48 hours, satisfaction to participate in the study and patients with natural teeth.
Exclusion criteria: Specify any damage caused by endotracheal intubation, extubation before 5 days and patient death within 5 days of follow-up.
Intervention groups
Intervention group 1: Washing of mouth and teeth with 10 cc chlorhexidine 0.2% three times of day until 5 days.
Intervention group 2: Washing of mouth and teeth with 20-25 drops irsha 0.2% three times of day until 5 days.
Main outcome variables
Incidence of pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022681N2
Registration date:2020-04-30, 1399/02/11
Registration timing:registered_while_recruiting
Last update:2020-04-30, 1399/02/11
Update count:0
Registration date
2020-04-30, 1399/02/11
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 195 1374
Email address
alikiaiib@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chlorhexidine mouthwash with irsha mouthwash drop on probable ventilator-associated pneumonia in intensive care unit
Public title
Comparison of the effect of chlorhexidine mouthwash and irsha mouthwash drop in the prevention of pulmonary infection in hospitalized patients in the intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Requires mechanical ventilation for at least 48 hours
Satisfaction to participate in the study
Patients with natural teeth
Exclusion criteria:
Specify any damage caused by endotracheal intubation.
Extubation before 5 days
Patient death within 5 days of follow-up
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 80 intubated patients in intensive care unit are enrolled in the study according to inclusion and exclusion criteria and are divided into two groups with blocking method and by Random Allocation Software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded by the type of medication used in the intensive care unit due to their intubation and relaxation, the drugs are also prepared in separate containers with numbers, and the nurse who used the medication for the patients does not know the type of drugs. After collecting the information, it enters the software by numbering, and after performing statistical analysis and completion of the work, the codes are determined.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUI.MED.REC.1398.414
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 incidence
Timepoint
After using the drug on a daily basis up to 5 days
Method of measurement
Clinical pulmonary infection score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: washing of mouth and teeths with 10 cc chlorhexidine 0.2% three times of day until 5 days.
Category
Prevention
2
Description
Intervention group: washing of mouth and teeths with 20-25 drops irsha 0.2% three times of day until 5 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Babak Alikiai
Street address
Shohadaye Sofe St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayesh Haghjoo
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
haghjoo@med.mui.ac.ir
Web page address
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
Babak Alikiai
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohadaye Sofe St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alikiaiib@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiai
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohadaye Sofe St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alikiaiib@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiai
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shohadaye Sofe St.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alikiaiib@med.mui.ac.ir
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
Information belongs to government agency
Study Protocol
No - There is not 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because the information belongs to a government agency, it cannot be shared.
When the data will become available and for how long
Any time
To whom data/document is available
Any person
Under which criteria data/document could be used
Under any circumstances
From where data/document is obtainable
Any person, any time
What processes are involved for a request to access data/document