Comparison of the effect of selective oral decontamination regimen and chlorhexidine on rate of ventilator-associated pneumonia in patients admitted to the intensive care unit care of Beheshti hospital in Kashan 2023
Determining the effect of selective oral decontamination regimen and chlorhexidine on rate of ventilator-associated pneumonia
Design
A community-based, pragmatic, control group clinical trial, randomized with parallel groups.
Settings and conduct
Intervention in the first group: Patients will receive 2% chlorhexidine mouthwash every 6 hours for 4 days. In the second intervention group: patients will receive mouthwash with SOD solution by the researcher in the special care department at the same time as the previous group. Then, ventilator-associated pneumonia will be reassessed at the time of admission to the intensive care unit and 96 hours later.
Participants/Inclusion and exclusion criteria
Entry criteria: age between 18 to 65 years old; not having diseases such as cancer, diabetes and chronic obstructive pulmonary disease; not using drugs that weaken the immune system.
No entry conditions: having more than 48 hours of mechanical ventilation before admission; requiring CPR.
Intervention groups
First intervention group: 48 patient will be rinsed with 2% chlorhexidine solution every 6 hours for 4 days by the researcher.
The second intervention group: 48 patient will be rinsed every 6 hours for 4 days using SOD solution containing 2% vancomycin, 2% gentamicin and 2% colistin by the researcher.
Control group: no intervention will be done by the researcher in patiants (48 sample) and they will receive routine ward care (drug therapy, mouthwash if necessary).
Main outcome variables
Body temperature; lung infiltration; Pao2/FIO2; leukocyte count; culture of tracheal secretions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231007059641N1
Registration date:2023-12-28, 1402/10/07
Registration timing:registered_while_recruiting
Last update:2023-12-28, 1402/10/07
Update count:0
Registration date
2023-12-28, 1402/10/07
Registrant information
Name
IRAN Kamkary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5500 3140
Email address
mehdy5100221976@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of selective oral decontamination regimen and chlorhexidine on rate of ventilator-associated pneumonia in patients admitted to the intensive care unit care of Beheshti hospital in Kashan 2023
Public title
The effect of selective oral decontamination regimen and chlorhexidine on rate of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between18 to 65 years old
Not having diseases such as cancer, diabetes and chronic obstructive pulmonary disease
Not using drugs that weaken the immune system
Exclusion criteria:
Having more than 48 hours of mechanical ventilation before admission
Requiring CPR
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by block randomization method with 10 blocks and using the random number table of Allocation Random software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research (Allocation Concealment).The sample allocation ratio (Allocation 1:1) will be in two groups of intervention and control (Assignment). Then, based on the obtained blocks and in the order of allocation, the intervention will be done. Blinding will not occur in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.140
Health conditions studied
1
Description of health condition studied
Ventilator associated pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Ventilator-associated pneumonia
Timepoint
At the time of admission and 96 hours after that
Method of measurement
To investigate pneumonia, the patient's body temperature using a mercury thermometer, the number of blood leukocytes using a venous blood test, pulmonary infiltration using chest X-ray, tracheal tube secretions using suction, Pao2 using ABG and fio2 using Pulse oximetry is measured.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Each patient will be rinsed with 2% chlorhexidine solution every 6 hours for 4 days by the researcher.
Category
Prevention
2
Description
The second intervention group: Each patient will be rinsed every 6 hours for 4 days using SOD solution containing 2% vancomycin, 2% gentamicin and 2% colistin by the researcher
Category
Prevention
3
Description
Control group: No intervention will be done by the researcher and they will receive routine ward care (drug therapy, mouthwash if necessary).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Mehdi kamkari
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
mehdy5100221976@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mahdye Sabery
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5510 3140
Email
Dsabery@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahdye Sabery
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5510 3140
Email
Dsabery@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahdye Sabery
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5510 3410
Email
Dsabery@yahoo.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
Data of participants are confidential.
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