Comparative study of the effectiveness of mouthwash containing either ozone water or chlorhexidine in the prevention of oral lesions and ventilation associated pneumonia in mechanically ventilated patients
Introduction:
Oral health is one of the most common measures for assessing personal well-being. Intubation of ICU inpatients endangers their oral health and increases their susceptibility to pneumonic diseases. This study was conducted to compare the effectiveness of two mouthwashes, containing either chlorhexidine or ozonized water, in preventing oral lesions and ventilator associated pneumonia (VAP).
Materials and methods:
Designed as a clinical trial, 74 patients were selected on the basis of accessibility and convenience, while considering the study criteria. The demographic information of all patients was gathered using a questionnaire. Patients were randomly assigned to either the control group (35 patients) or the test group (39 patients). Patients in the control or test group used a mouthwash containing either chlorhexidine (0.2% by wt.) or ozonized water (0.05 ppm by wt.) three times per day, respectively. To study oral lesions, the validated Beck oral assessment scale (BOAS) was used. The patients were also assessed using the clinical pulmonary infection score (CPIS) scale to evaluate them in terms of the VAP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080523520N1
Registration date:2015-10-30, 1394/08/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Nasrin Hanifi
Name of organization / entity
Zanjan University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 2513
Email address
nasrinhanifi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2013-10-17, 1392/07/25
Expected recruitment end date
2014-03-17, 1392/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of mouthwash containing either ozone water or chlorhexidine in the prevention of oral lesions and ventilation associated pneumonia in mechanically ventilated patients
Public title
Comparative study of the effectiveness of mouthwash containing either ozone water or chlorhexidine in the prevention of oral lesions and ventilation associated pneumonia in mechanically ventilated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who for 12 hours intubated and connect them mechanical ventilation and remained under mechanical ventilation during the study; patients aged 18-70 years; women who were not pregnant; no artificial teeth; had not severe anemia; had not alcohol poisoning; bleeding or sores in the mouth had not
Exclusion criteria:
Patients with mechanical ventilation ended in less than 48 hours; the patient died or for any reason or legal guardians of the patient and his doctor to participate in the study were withdrawn; despite the digestive tubes were vomiting during the study.
Age
From 18 years old to 76 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Had not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Azadi Square,Zanjan University of Medical Science
City
Zanjan
Postal code
13191-45156
Approval date
2013-09-21, 1392/06/30
Ethics committee reference number
ZUMS.REC.1392.106
2
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Azadi Square,Zanjan University of Medical Science
City
Zanjan
Postal code
13191-45156
Approval date
2013-09-21, 1392/06/30
Ethics committee reference number
ZUMS.REC.1392.106
Health conditions studied
1
Description of health condition studied
Diseases of the respiratory system
ICD-10 code
10
ICD-10 code description
Chapter X Diseases of the respiratory system (J00-J99)
Primary outcomes
1
Description
Oral lesions
Timepoint
after intervention, the second, third and fourth day of hospitalization
Method of measurement
Beck
Secondary outcomes
1
Description
VAP
Timepoint
The first , third and fourth day of hospitalization
Method of measurement
CPIS
Intervention groups
1
Description
In intervention group mouthwash with 0.05 ppm ozone water
Category
Prevention
2
Description
In the control group mouthwash containing 0.2% chlorhexidine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Science
Full name of responsible person
Mosavi Hospital
Street address
masome masomi
City
Gavazng road, Mousavi Hospital, part icu
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
zanjan university of medical sciences
Full name of responsible person
Nasrin hanifi
Street address
Azadi Square, Tehran University of Medical Sciences
City
zanjan
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی زنجان
Grant code / Reference number
414
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
zanjan 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
Zanjan University of Medical Scienses
Full name of responsible person
Masome masomi
Position
nursing student of M.S in critical care nursing
Other areas of specialty/work
Street address
Parvin sequar , faculty of Nursing and Midwifery
City
zanjan
Postal code
13191-45156
Phone
+98 24 3377 2513
Fax
+98 24 3377 2514
Email
mmasoumi37@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
zanjan university of medical scienses
Full name of responsible person
Nasrin hanifi
Position
PHD/ Assistant Professor,
Other areas of specialty/work
Street address
Parvin sequar , facultyl of Nursing and Midwifery
City
zanjan
Postal code
4515789589
Phone
+98 24 3377 2513
Fax
+98 24 3377 2514
Email
nasrinhanifi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
zanjan university of medical sciences
Full name of responsible person
Nasrin hanifi
Position
PHD, Assistant Professor,
Other areas of specialty/work
Street address
Parvin eatesami sequar , faculty of Nursing and Midwifery
City
zanjan
Postal code
4515789589
Phone
+98 24 3377 2513
Fax
+98 24 3377 2514
Email
nasrinhanifi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)