Comparison of effect of three mouthwashs, chlorhexidin, sodium bicarbonate and salin on bacterial colonization of endotracheal tubes and incidence of pneumonia in patients undergoing open heart surgery in Imam Ali Hospitat 2012-2013.
Objective: to compare the incidence of pneumonia and bacterial colonization of endotracheal tubes in patients using three mouthwash solutions: sodium bicarbonate, chlorhexidin and normal saline.
study design: double-blind.
Study population: Patients undergoing open heart surgery and admitted to the intensive care unit at Imam Ali hospital.
Major inclusion criteria:having an endotracheal tube, being under mechanical ventilation, absence of pneumonia and periodontal disease.
Major exclusion criteria: removal of endotracheal tube within 6 hour after surgery.
Sample Size: 165 patients.
Intervention: using three mouthwash solutions: sodium bicarbonate, chlorhexidin 0.2% and normal saline.
Time of intervention:All of the patients should wash their mouths with the mouthwash from 24 hours before surgery and twice a day (8 am and 8 pm). Immediately after surgery, until extubation, mouthwash will be conducted by the researcher in ICU for 48-72 hours. After discharging from ICU, up to 7 days, mouthwash is performed by patients.
Primary outcomes: Being diagnosed with nosocomial pneumonia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207204736N3
Registration date:2012-07-26, 1391/05/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-26, 1391/05/05
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of three mouthwashs, chlorhexidin, sodium bicarbonate and salin on bacterial colonization of endotracheal tubes and incidence of pneumonia in patients undergoing open heart surgery in Imam Ali Hospitat 2012-2013.
Public title
Effect of mouthwash on tracheal colonization and pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria consist of: lack of history of recent intubation; no history of recent surgery; no sensitivity to mouthwash solutions; having endotracheal tube; no symptoms of aspiration; the absence of debilitating disease of immune system; lack of use immunosuppressive drugs; age between 18-65 years and lack of periodontal disease.
Exclusion criteria consist of: the patient died during surgery or the day after surgery; tracheal tube out before 6 hours after surgery; view aspiration revealed and incidence of allergic and unwanted reactions to chlorhexidin.
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:
165
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
kermanshah University of Medical Sciences
Street address
Shahid Beheshty BLV
City
Kermanshah
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
4147/420/7/پ
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J18.8
ICD-10 code description
Other pneumonia, organism unspecified
Primary outcomes
1
Description
The amount of bacterial colonization of endotracheal tube
Timepoint
When extubation of tracheal tube
Method of measurement
Doing culture from endotracheal tube cuff in a laboratory
2
Description
Incidence of pneumonia
Timepoint
From entering to ICU and up to 7 days after admitted to surgical ward
Method of measurement
Chest radiography, measurement of body temperature, A complete blood count
Secondary outcomes
empty
Intervention groups
1
Description
For the first group, two times a day and for 7 days after surgery, chlorhexidin 0.2% solution is used.
Category
Prevention
2
Description
For the second group, two times a day and for 7 days after surgery, solution of sodium bicarbonate is used.
Category
Prevention
3
Description
For the third group, two times a day and for 7 days after surgery, normal saline solution, is used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Gholamreza Morady
Street address
Shahid Beheshty Blvd,
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafy
Street address
Shahid Beheshty Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Dolat abad, Kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 1827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Dolat abad, Kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 1827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Dolat Abaad, Kermanshah School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 1827 9394
Fax
Email
akhatony@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)