The aim of this study is to determine the effects of oral care program 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 80 admitted patients of Amin hospital in Isfahan 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, oral care will be implemented. every 12 hours , teeth will be brushed with chlorhexidine solution and every 4 hours the lips moisture.Both groups will be examined in terms of pneumonia incidence based on the CPIS forms at the first, third, and fifth days of the study .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101631200N2
Registration date:2017-10-23, 1396/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-23, 1396/08/01
Registrant information
Name
Vajihe Atashi
Name of organization / entity
Nursing Faculty of Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
vajiheatashi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral care program on prevention of ventilator-associated pneumonia in intensive care unit patients
Public title
The effect of oral care program 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:
80
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
Isfahan University of Medical Science
Street address
Hezar-Jerib Ave., Isfahan
City
Isfahan
Postal code
81746 73461
Approval date
2016-07-27, 1395/05/06
Ethics committee reference number
IR.MUI.REC.1395.3.361
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
Secondary outcomes
1
Description
Oral Health
Timepoint
Daily for 5 days
Method of measurement
BOAS
Intervention groups
1
Description
Adjusting the pressure of the cuff of the endotracheal tube 20 using a special manometer.Brushing all internal and external surfaces of the teeth, gums and tongue for 2 min using a baby toothbrush and antimicrobial chlorhexidine0.12% every 12 hours.Moisturizing all surfaces of the oral mucosa, gums, and tongue of the patient using swabs and moisturizing gel every 4 hours.
Thin layer of petroleum jelly was applied to the lip
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
Amin Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Vajihe Atashi
Street address
Hezar-Jerib Ave., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Science
Full name of responsible person
Vajihe Atashi
Position
Nursing Phd Student
Other areas of specialty/work
Street address
Hezar-Jerib Ave., Isfahan
City
Isfahan
Postal code
Phone
+98 314390115
Fax
Email
vajiheatashi@gmail.comvajiheatashi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Vajihe Atashi
Position
Nursing Phd Student
Other areas of specialty/work
Street address
Hezar-Jerib Ave., Isfahan
City
Isfahan
Postal code
Phone
+98 314390115
Fax
Email
vajiheatashi@gmail.comvajiheatashi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Vajihe Atashi
Position
Nursing Phd Studet
Other areas of specialty/work
Street address
Hezar-Jerib Ave, Isfahan
City
Isfahan
Postal code
81746 73461
Phone
+98 314390115
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)