The aim of this study is to determine the effects of systematic oral care on pneumonia incidence for mechanically ventilated patients at Intensive Care Unit. This study is a randomized controlled clinical trial which will be carried out on 100 admitted patients of Imam Khomeyni and Imam Reza hospitals in Sari and Amol respectively. The patients will be randomly assigned in to two control and intervention groups. In control group, Routine oral care will be done and in intervention group, systematic oral care will be implemented in such a way that patients will be scored with Beck tool to determine the times of oral care.
In each event of oral care, teeth will be brushed and chlorhexidine solution is sprayed on teeth and the lips moisture. Using Beck tool, oral condition of the patient will be examined on a daily basis. At first, third and fifth days of study condition of Mucosal-Plaque Score will be investigated in both groups. Both groups will be examined in terms of pneumonia incidence based on the CPIS forms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100424342N1
Registration date:2015-11-04, 1394/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Vida Shafipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
v.shafipour@mazuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology , Mazandaran University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of systematic oral care on the preventing ventilator associated pneumonia in critically ill patients
Public title
The effect of systematic oral care on pulmonary infection in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Having intubation during study, Age between 18 to 65 years, Admision on ICU less than 12 hours, No further intubation, No extreme trauma of the face and mouth, No current hospitalization in other parts of the hospital, No pregnancy, Not having chronic disease and immune disorder, Patient with natural teeth, Lack of lung disease, Pneumonia and Sepsis according to CPIS tools.
Exclusion Criteria: Transferring the patient from ICU or his/her death, Unwillingness to continue the study from the patient's legal guardian, Less than 48 hours under mechanical ventilation, Removing intubation before end of study, Allergic to chlorhexidine
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
Street address
Moalem Square
City
Sari
Postal code
Approval date
2015-09-12, 1394/06/21
Ethics committee reference number
IR.Mazums.REC.94-1672
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia
ICD-10 code
J95.8
ICD-10 code description
Other Postprocedural Respiratory Disorders
Primary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
First, Third, Fifth Day
Method of measurement
CPIS
2
Description
Oral Health
Timepoint
Daily for 5 days
Method of measurement
BRUASHED Scale
3
Description
Mucosal-Plaque Position
Timepoint
First, third, Fifth Day
Method of measurement
Mucosal-Plaque Score
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, at first, oral condition of the patient will be scored by Beck form to determine the times of oral care. During each oral care, Endotracheal tube cuff pressure will be set in the range of 20 cm H2O. Teeth will be brushed by children soft toothbrush and toothpaste and washed with normal saline serum with suction in the same time. the amount of Mouthwash solution include 5 ml of % 12 Chlorhexidin will be sprayed on teeth. So the oral cavity’ s suction will be done in mouth and throat simultaneous . Finally, lips get wet using moisturizing cream.
Category
Prevention
2
Description
In the control group, oral care will be performed by staff based on the daily routine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Sari
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Amol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
Full name of responsible person
Hosin Enayati
Street address
Moalem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences