objective : comparison of oral rinse with chlorhexidine 0/2 and 2 % on the oropharyngeal colonization and ventilator associated pneumonia in adult intensive care units. design: randomized clinical trial, double blind. method: 112 adult patients ,age of 18 years and older that had inclusion criteria randomly assigned in two groups, chlorhexidine 0/2 % group which receive oral care protocol with chlorhexidine 0/2% and chlorhexidine 2% group which receive oral care protocol with chlorhexidine 2%.Before oral care initiation, oral assessment is done and cultures from oropharyngeal and tracheal is obtained and sent to laboratory. Patients followed and ventilator associated pneumonia is checked daily until Patients are intubated or they are transferred to ICU or discharged ,or they are diagnosed as pneumonia, or died in 28 days. 4) Study samples are Patients admitted to Nemazee and Rajaee hospitals ICUs who are intubated and mechanically ventilates for at least 48 hours. Inclusion and exclusion criteria: main inclusion criteria were : age 18 years and older, intubated and mechanical ventilated within 48 hours of admission. main exclusion criteria were: a clinical diagnosis of pneumonia at the time of admission, readmission to the ICU. 5) interventions: oral care protocol with chlorhexidine 0/2% in chlorhexidine 0/2% group and same oral care protocol with chlorhexidine 2% in chlorhexidine 2% group, examination for pneumonia daily and sending oropharyngeal and tracheal cultures on admission and when patients are extubated or transferred or discharged or diagnosed pneumonia or died in 28 days. 6) main outcomes, the rate of ventilator associated pneumonia and oropharyngel colonization. Variables : radiologic, clinical and laboratory findings.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100624382N1
Registration date:2015-11-26, 1394/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Laila Zahed
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 3651
Email address
mansoorip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-05, 1394/01/16
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effects of oral rise with 0/2 and 2% chlorhexidine on oropharyngeal colonization and ventilator associated pneumonia in adult intensive care units
Public title
the effects of oral rise with 0/2 and 2% chlorhexidine on oropharyngeal colonization and ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18 years and older; informed consent; patients intubated and who on mechanical ventilation within 48 hours of admission; without a clinical diagnosis of pneumonia at the time of admission ; not to be pregnant ; without significant oral, facial trauma; not to readmitted to the ICU ; without known hypersensitivity to chlorhexidine; without an immunosuppression (disease or drug induced, e.g. organ transplant patient or those on long term steroid therapy); not to hospitalized for burn injury.
Exclusion criteria: aspiration; a diagnosed thrombocytopenia (platelet less than 40000); INR above 2 or other coagulopathy.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
93-7363
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J20-J22
ICD-10 code description
other acute lower respiratory infections
Primary outcomes
1
Description
oropharyngeal colonization
Timepoint
before intervention and if had exclusion criteria
Method of measurement
send culture and report semiquantitative
Secondary outcomes
1
Description
ventilator associated pneumonia
Timepoint
before, during and until 48hours and if had exclusion criteria
Method of measurement
clinical pulmonary infection score and clinical diagnose and start new antibiotic by intensivist
Intervention groups
1
Description
In control group, oral care protocol include, suction, oral assessment, brushing and rubbing saturated oral foam application of chlorhexidine 0/2% 10ml on gum, mucosa, teeth, hard palate, every 12 hours is done.
Category
Prevention
2
Description
In intervention group, oral care protocol include, suction, oral assessment, brushing and rubbing saturated oral foam application of chlorhexidine 2% 10ml on gum, mucosa, teeth, hard palate, every 12 hours is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Leila Zahed
Street address
Nemazee Square, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Leila Zahed
Street address
Chamran Blvd. , Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Science
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Street, Shiraz
City
Shiraz
Grant name
93/451495
Grant code / Reference number
93-7363
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shiraz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences-Fatemeh (PBUH) School of Nursing & Midwifery
Full name of responsible person
Leila Zahed
Position
MS(intensive care) Student
Other areas of specialty/work
Street address
Zand Street, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4257
Fax
+98 364742252
Email
lailazahed57 @ gmail. com;
Web page address
stud3521091813@sums. ac. ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Fatemeh(PBUH) School of Nursing & Midwifery
Full name of responsible person
Parisa Mansoori
Position
MS-Faculty College
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing & Midwifery Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4257
Fax
+98 36474252
Email
mansoorip@sums. ac. ir
Web page address
nurs-midwif-sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Zahed
Position
MS(intensive care)Nursing Student
Other areas of specialty/work
Street address
Zand Steet, Shiraz
City
Shiraz
Postal code
7134814336
Phone
+98 71 8897 7971
Fax
+98 32359317
Email
lailazahed57@ gmail. com
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)