The aim of this study is to determine effect of hydrogen peroxide oral rinse on incidence of ventilator-associated pneumonia in hospitalized patient in critical care unit. Inclusion criteria: more than 18 years old, under mechanical ventilation for more than 48 hours, no signs of aspiration, no pneumonia, no contraindications to oral care, lack of oral trauma, no contraindication to elevation of head of bed at least 30 degrees. Exclusion criteria: if a patient separated from mechanical ventilation for less than 48 hours. The society of under study: our samples include of patients, which hospitalized in ward of intensive care unit in Fatemiah and Amir-almomenin hospitals in Semnan that have inter criteria situation. Sample size: Study conducted on 15 subjects from each group using a significance level of 5% and the 80% formula, samples in each group calculated. Age, APACHE II score and type of intensive care unit are similar in the experimental and control group. Intervention in both groups is the same and randomize. Patients of experimental and control groups receive daily twice hydrogen peroxide 3% oral rinse and normal saline 0.9% oral rinse, respectively. Patients are mouthwash for 5 days and ventilator-associated pneumonia assessed in 1th and 5th days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305236318N2
Registration date:2013-06-17, 1392/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-06-05, 1392/03/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydrogen peroxide oral rinse on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit
Public title
Effect of hydrogen peroxide oral rinse on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: more than 18 years old, under mechanical ventilation for more than 48 hours, no signs of aspiration, no pneumonia, no contraindications to oral care, lack of oral trauma, no contraindication to elevation of head of bed at least 30 degrees. Exclusion criteria: if a patient separated from mechanical ventilation for less than 48 hours.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Basij Bulvar, Semnan
City
Semnan
Postal code
3513138111
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
92/306537
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia
ICD-10 code
j69.0
ICD-10 code description
Pneumonitis due to food and vomit
Primary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
In 1th and 5th days
Method of measurement
The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia
Secondary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
In 1th and 5th days
Method of measurement
The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia.
Intervention groups
1
Description
In intervention group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml hydrogen peroxide solution 3% Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days.
Category
Prevention
2
Description
In control group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml saline normal 0.9% Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences,Fatemiah Hospital and Amir-Almomenin Hospital
Full name of responsible person
Monir Nobahar
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Semnan, Boulvar Basij, University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciencesl
Full name of responsible person
Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciencesl, Nursing and Paramedical University
City
Semnan
Postal code
35131338111
Phone
+98 23 1335 4170
Fax
Email
nobahar43@sem-ums.ac.ir nobahar43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
nobahar43@sem-ums.ac.ir nobahar43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
nobahar43@sem-ums.ac.ir nobahar43@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)