Comparison of mucoadhesive polymer gel containing chlorhexidine %0.2 and the solution of chlorhexidine%0.2 in the prevention of ventilator-associated pneumonia in patients who admitted in intensive care unit
The aim of this study is to investigate the effect of mucoadhesive gel containing chlorhexidine in the prevention of ventilator-associated pneumonia in patients who admitted in the intensive care unit. This study is a clinical trial. 64 patients who connected to the ventilator that age between 20 and 50 years old will be enrolled in the study. If patients less than seven days to be extubated or to be discharged they will be excluded. Patients will be randomly divided into two groups. The first group will be received Mucoadhesive gel of chlorhexidine and the second group will be received chlorhexidine mouthwash. Every three days the incidence of ventilator-associated pneumonia will be assessed by Clinical Pulmonary Infection Score (CPIS) for 7 to 14 days. Finally, connection to ventilator days, length of intensive care unit stay and mortality rate will be compared between the two groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201602095363N9
Registration date:2016-12-21, 1395/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of mucoadhesive polymer gel containing chlorhexidine %0.2 and the solution of chlorhexidine%0.2 in the prevention of ventilator-associated pneumonia in patients who admitted in intensive care unit
Public title
The effect of mucoadhesive polymer gel containing chlorhexidine %0.2 in the prevention of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20 and 50 years, Intubated patients and under mechanical ventilation, patients who have tooth, patients who are not pregnant, patients who have not Tracheostomy or T tube, Do not feeding from jejunostomy, don't have parental feeding.
exclusion criteria: Admission less than one week, Death in less than 7 days after intubation,Extubation in less than 7 days
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of random numbers will be used for Randomization in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences
City
Zanjan
Postal code
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
ZUMS.REC.1394.224
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J69.8
ICD-10 code description
Pneumonitis due to other solids and liquids
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
Third day, Sixth day, Ninth day, The twelfth day
Method of measurement
Clinical Pulmonary Infection Score
Secondary outcomes
1
Description
Connection to ventilator days
Timepoint
End of the study
Method of measurement
Records
2
Description
length of Intensive Care Unit stay
Timepoint
End of the study
Method of measurement
Records
3
Description
mortality during hospitalization in Intensive Care Unit
Timepoint
End of the study
Method of measurement
Records
Intervention groups
1
Description
The first group 5 ml chlorhexidine 0.2% product of Behsa pharmaceutical company which will be produced to mucoadhesive form by the School of Pharmacy of Zanjan University of Medical Sciences as mouthwash will be received three times a day
Category
Treatment - Drugs
2
Description
The control group 5 ml oral solution containing chlorhexidine %0.2 product of Behsa pharmaceutical company as mouthwash will be received three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi Hospital
Full name of responsible person
Dr Taraneh Naghibi
Street address
Mosavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research of Zanjan University
Full name of responsible person
Vice- Chancellor for Research of Zanjan University of Medical Sciences, Shoghli MD, PhD
Street address
Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor for Research of Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Ali Zargar
Position
Medical Student
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
Zargar.ali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship, Assistant Professor
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Road, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
ICU Fellowship, Assistant Professor
Other areas of specialty/work
Street address
Mosavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Postal code
Phone
00
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)