Pneumonia is a common cause of morbidity and mortality in patients under mechanical ventilation in ICU. One of the ways to decrease these infections is Selective decontamination of the digestive tract and oropharynx which decrease oropharyngeal colonization in the stomach and intestines. However, this method may cause antibiotics resistance. In recent years the use of herbal medicines due to antibacterial, antifungal, anticancer and less side effects are common for oral health. In this study the effect of Persica as herbal remedies without side effects compared with chlorhexidine in prevention of ventilator-associated pneumonia in ICU patients will be evaluated.
This study is a double blind randomized clinical trial. The study population included patients admitted to the ICU that are under to mechanical ventilation. In the first group, 10cc of chlorhexidine 2.0% will be used as a mouthwash for 6 minutes. In the second group instead of chlorhexidine , 10cc persica will be used for 6 minutes. The incidence of ventilator-associated pneumonia will be measured by CPIS score every three days as the primary outcome. The number of days under mechanical ventilation, days of hospitalization in ICU and mortality and complications between the two groups will be evaluated as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022032676N1
Registration date:2017-04-22, 1396/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-22, 1396/02/02
Registrant information
Name
Farshad Hassanzadeh Kiabi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4000
Email address
fhasanzadehk@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mazandaran University of Medical Science
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-09-01, 1395/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of persica and chlorhexidine on the prevention of ventilator Associated pneumonia
Public title
Comparing the effect of persica and chlorhexidine on the prevention of ventilator Associated pneumonia in patient admitted in ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 18 and 65; be intubated; be under mechanical ventilation in 48 hours after admission. Exclusion criteria: dissatisfaction with the patient at any time in the study; Re - intubation; autoimmune diseases and malignancies; history of radiotherapy and the use of immunosuppressive drugs such as corticosteroids and immunosuppressive diseases; mouthwash allergy history; asthma and allergic rhinitis and dermatitis; previous use of antibiotics in the hospital in two weeks before; history of any antimicrobial mouthwash two weeks before hospitalization; Oral mucositis and periodontal disease; patients with pneumonia; pregnant women; history of lung disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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 for Biological Research of Mazandaran University of Medical Science
Street address
Valis Asr Bolovar, Sari
City
Sari
Postal code
Approval date
2017-01-30, 1395/11/11
Ethics committee reference number
IR.MAZUMS.REC.95.2356
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J13; J14;
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae; Pneumonia due to Haemophilus influenzae; Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
pneumonia
Timepoint
3 days
Method of measurement
CPIS
Secondary outcomes
1
Description
complication
Timepoint
3 days
Method of measurement
examination
2
Description
intubation duration
Timepoint
extubation
Method of measurement
examination
3
Description
ICU mortality
Timepoint
dead time
Method of measurement
observation
Intervention groups
1
Description
chlorhexidin mouth wash
Category
Treatment - Drugs
2
Description
Persica mouth wash
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Shah Heydari
Street address
Imam Khomeini Hospital, Razi Street, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for Research, Mazandran University of Medical Sciense
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moallem square, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for Research, Mazandran University of Medical Sciense
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
Department of Anesthesiology, Mazandaran University of Medical Science
Full name of responsible person
Frashad Hassanzadeh Kiabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Rzai Street, Sari
City
Sari
Postal code
Phone
+98 113337770
Fax
Email
fhasanzadehk@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiolog, Mazandaran University of Medical Science
Full name of responsible person
Farshad Hassanzadeh Kiabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Razi Street, Sari
City
Sari
Postal code
Phone
+98 113337770
Fax
Email
fhasanzadehk@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiolog, Mazandran University of Medical Science
Full name of responsible person
Farshad Hassanzadeh Kiabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Razi Street, Sari
City
Sari
Postal code
Phone
+98 113337770
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)