The aim of this study is to determine effect of Matrica versus chlorhexidine oral rinse on incidence of ventilator-associated pneumonia in hospitalized patient in critical care unit.
Inclusion criteria include more than 18 years old, under mechanical ventilation for more than 48 hours, no pneumonia, lack of oral trauma, no immunosuppressive diseases.
Exclusion criteria: if a patient separated from mechanical ventilation for less than 48 hours.
Sample size: Study conducted on 30 subjects from each group using a significance level of 5% and the 90% formula, samples in each group calculated.
Intervention in both groups is the same and randomize. Patients of experimental and control groups receive daily twice Matrica oral rinse and Chlorhexidine 0.2% oral rinse, respectively. Patients are mouthwash for 7 days and ventilator-associated pneumonia assessed in 7th days by Clinical Pulmonary Infection Score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303058288N3
Registration date:2013-07-27, 1392/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-27, 1392/05/05
Registrant information
Name
Ali Maarefvand
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 25 1667 2803
Email address
a.moarefvand@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2013-04-18, 1392/01/29
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Matrica oral rinse on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unitpatients
Public title
Effect of Matrica oral rinse on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: more than 18 years old, under mechanical ventilation for more than 48 hours, no pneumonia, lack of oral trauma, no immunosuppressive diseases.
Exclusion criteria: if a patient separated from mechanical ventilation for less than 48 hours.
Intervention Group: While the head of the bed is elevated, Mouthwash is done by a long-handled brush and one tablespoon of Matrica in a glass of diluted solution serum. Mouthwash is done about 10 minutes twice a day for one week. Also pharyngeal suctioning is done before and after mouthwash. After one week, Occurrence or non-occurrence of Ventilator-associated pneumonia assess by CPIS score as the primary outcome variable.
Category
Other
2
Description
Control group: in this group, mouthwash is done by a long-handled brush and chlorhexidine 0.2%. Duration of mouth care is one week. After one week, the occurrence of Ventilator-associated pneumonia evaluate by CPIS.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom University of Medical Sciences
Full name of responsible person
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Street address
No. 6, Rahimzadeh alley, Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Position
PhD in Nursing
Other areas of specialty/work
Street address
No. 6, Rahimzadeh alley, Valiasr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
mheidari@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Position
PhD in Nursing
Other areas of specialty/work
Street address
No. 6, Rahimzadeh alley, Valiasr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 6645 8587
Fax
Email
mheidari@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Maarefvand
Position
The Bachelor of Science in Nursing
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 66418587
Fax
Email
A.Moarefvand@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)