Comparison of two methods of oral care on oral health and the prevention of ventilator-associated pneumonia in mechanically ventilated patients in intensive care unit
The aim of this study is to compare two methods of oral care on oral health and the prevention of ventilator-associated pneumonia in mechanically ventilated patients. This study is a randomized controlled clinical trial which will be done on 68 patients who will be admitted to ICUs Of Imam Khomeini hospital in Ahwaz and meet inclusion criteria of. The patients will be randomly assigned into 2 equal 34 persons. In group A, all surfaces of mouth, gingiva, tongue, throat and teeth will be brushed by 20 cc of Chlorhexidine. In Group B, the same intervention will be done with chlorhexidine and Swabs. Mouth washing will be repeated every 12 hours to 5 days . Each intervention will be taken about 20 minutes. In both groups A and B oral health status, will be recorded, the daily at 6 pm according to the BRUSHED form. At the end of the study (fifth day) both groups A and B will be examined, terms of infection with and without of ventilator-associated pneumonia based on the CPIS forms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050813278N1
Registration date:2013-05-25, 1392/03/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Maryam Razeh
Name of organization / entity
Nursing and Midwifery School, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
m.razeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of oral care on oral health and the prevention of ventilator-associated pneumonia in mechanically ventilated patients in intensive care unit
Public title
The effect of oral care on pulmonary infection in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: Age between 18 to 65 years, Having oral endotracheal tube, lake of pneumonia before the start of the study according to recognize a physician, the absence of immunosuppressive diseases according to recognize a physician, Be permitted to perform oral care for patients according to doctor, Not having dentures, No history of allergy to chlorhexidine, The absence of wound, infection and oral trauma, Without underlying lung problems (chronic obstructive pulmonary disease, lung cancer, trauma to the chest). Exclusion criteria were: death at the time of the study, Separation from mechanical ventilation at the time of the study, Re- intubation at the time of the study, initiation of pneumonia
48 hours after the start of the study, according to medical study
View apparent aspiration
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:
68
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
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
D/P/16/35/9/756
Health conditions studied
1
Description of health condition studied
Oral Health
ICD-10 code
K00-14
ICD-10 code description
Disorders of tooth development and eruption
2
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
Oral Health
Timepoint
Daily for 5 days
Method of measurement
BRUASHED Scale
2
Description
Pneumonia
Timepoint
Fifth Day
Method of measurement
CPIS Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: chlorhexidine mouthwash 0/2%, 2times a day for 5 days, using Children toothbrush
Category
Prevention
2
Description
Control group: chlorhexidine mouthwash 0/2%, 2times a day for 5 days, using guaz
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ghlam Hossein Falahinia
Street address
Ahvaz, Pasdaran Av, Ghlam Hossein Falahinia
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
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, Hamadan 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
Department of Medical Surgical Nursing
Full name of responsible person
Ghlam Hossein Falahinia
Position
Nursing Masters
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Av
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
falahinia@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Ghlam Hossein Falahinia
Position
Nursing Masters
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
falahinia@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
maryam razeh
Position
Master Critical Care Nursing Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 1838 0439
Fax
+98 81 1838 0447
Email
m.razeh@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)