Background: Ventilator-associated pneumonia is the most common nosocomial infection in intensive care units (ICU), leading to increase in mortality and length of ICU and hospital stay as well as duration of mechanical ventilation and hospital charges. In this regard, the present study has been conducted to investigate the effect of planned nursing care protocols on the incidence of early ventilator-associated pneumonia. Methods: In a controlled clinical trial, 117 patients undergoing mechanical ventilation were evaluated in intensive care unit in the two groups including control (n=71) and the intervention (n=46); the former received the ward's routine care, and the latter planned nursing care protocols. Incidence of pneumonia was investigated using CPIS and Mini-BAL method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201178650N2
Registration date:2012-02-27, 1390/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Abbas Ebadi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
ebadi1347@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Health Research Center and Nursing Faculty of Baqiyatallah University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of planned nursing care protocols on the incidence of early ventilator-associated pneumonia
Public title
Effect of nursing cares on the incidence of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients, ranging in age from 18 to 65 years, admitted to intensive care units and intubated were entered in to the study if having no symptoms indicative of pneumonia (high fever, leukocytosis or leukopenia, lung infiltration, and purulent discharge) and underlying lung problems (chronic obstructive pulmonary disease, lung cancer, and chest trauma) and were monitored for 96 hours after intubation to be under the ventilation for more than 48 hours. Exclusion criteria: toothlessness, suspected pneumonia during intubation, pregnancy and lack of consent for participation by patients and their families, FiO2 >90 and/or PEEP >14cm H2O, and cardiopulmonary arrest and resuscitation.
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:
90
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
Nursing Faculty of Baqiyatallah University of Medical Sciences
Street address
Nursing Faculty, Araj, Aqdasieh
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
25
Health conditions studied
1
Description of health condition studied
pnuemonia associated- Ventilator
ICD-10 code
J20- J22
ICD-10 code description
Other acute lower respiratory infection
Primary outcomes
1
Description
incidence of early ventilator-associated pneumonia
Timepoint
96 hour after the intervention
Method of measurement
mini-BAL culture and CPIS
Secondary outcomes
1
Description
reduce of duration of ventilator
Timepoint
seprating of ventilator
Method of measurement
ventilator day
Intervention groups
1
Description
Oral hygiene using 0.2% chlorhexidine mouthwash every eight hours, teeth brushing every 12 hours , elevating the head of bed to 30-45 degrees, especially while gavaging in cases of no contraindications , maintaining the cuff pressure between 20-30 cm H2O , continuous subglottic suctioning , nurses' personal hygiene (hand washing) before and after contact with patients , sterilization observation and ventilator tube's replacement in cases of significant contamination.
Category
Prevention
2
Description
In control group routin nursing cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Health Research Center and Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Jonaidi Neematoggah
Street address
Health Research Center, Baqiyatallah University of Medical Sciences, Vanak sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health Research Center and Nursing Faculty of Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Abbas ebadi
Street address
Nursing Faculty, Araj, Aqdasiye
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing Faculty of Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Abbas Ebadi
Position
PhD of nursing, boss of Nursing Faculty
Other areas of specialty/work
Street address
Nursing Facultyof Baqiyatallah University of Medical Sciences, Araj, Aqdasiye
City
Tehran
Postal code
Phone
+98 21 4441 9393
Fax
Email
ebadi1347@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Abbas Ebadi
Position
PhD of nursing
Other areas of specialty/work
Street address
Nursing Faculty of Baqiyatallah University of Medical Sciences, Araj, Aqdasiye
City
Tehran
Postal code
Phone
+98 21 4441 9393
Fax
Email
ebadi1347@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)