Effects of Botanical mouthwash of Aloe Vera on ventilator associated pneumonia of patients having Endotracheal tube hospitalized in the Intensive Care Unit
This is a double blind clinical trial that will be performed to compare the effects of two mouthwashes (Aloe Vera and normal saline) on dental plaque index and pneumonia in shiraz namazi hospital. Patient or legal guardians and physician who diagnosed pneumonia are not aware of the type of the mouthwash. 79 patients having endotracheal tube will be chosen according to inclusion and exclusion criteria and will be divided in two groups randomly (Aloe Vera and normal saline). Oral care and mouth washing will be performed in intervention group by the use of 15 ml Aloe Vera mouthwash, every 12 hours and for 4 days and in control group by the use of 15 ml normal saline in the same way. Oral care in both groups will be done similarly. For collecting data (at first and 4 days later), dental plaque index (O'Leary) and modified clinical pulmonary infection score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052828134N1
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Nasrin mirbastegan
Name of organization / entity
shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
tannaz.saeidzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of SHahid Beheshti university of medical science
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Botanical mouthwash of Aloe Vera on ventilator associated pneumonia of patients having Endotracheal tube hospitalized in the Intensive Care Unit
Public title
Effects of Botanical mouthwash of Aloe Vera on ventilator associated pneumonia of patients having Endotracheal tube hospitalized in the Intensive Care Unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 18-65 years old; having endotracheal tube through the mouth; admitted to ICU less than 12 hours; having natural teeth;don't have history of use antibiotic two weeks ago; don't have pregnancy and no history of allergy to herbal compounds;don't have HIV and use of steroid drugs; not have an injury in the mouth and around it;not have pneumonia;don't have history of use antibiotic on two weeks ago;don't have leukopenia and noutropenia and serum albumin <2/5 mg/dl;
Exclusion criteria: to discharge from the ICU or die before completing the study; inclination to continue the study;>6 score of clinical pulmonary infection score on 12 hours first time admission
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
79
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti university of medical sciences
Street address
Side of Ayatollah Taleghani hospital, Shaheid Aarabi street, Yaman street, Shaheid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2015-12-14, 1394/09/23
Ethics committee reference number
ir.sbmu.phnm.1394.216
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
j15
ICD-10 code description
Influenza and pneumonia
2
Description of health condition studied
dental plaque
ICD-10 code
k03.6
ICD-10 code description
Deposits [accretions] on teeth
3
Description of health condition studied
dental plaque
ICD-10 code
k02.1
ICD-10 code description
Caries of dentine
Primary outcomes
1
Description
Pneumonia
Timepoint
Immediately before intervention and four days later
Method of measurement
Modified clinical pulmonary infection score
Secondary outcomes
1
Description
Dental plaque index
Timepoint
Immediately before intervention and four days later
Method of measurement
o'leary plaque index
Intervention groups
1
Description
intervention group: Using 15 ml of Aloe Vera mouthwash, every 12 hours, for 4 days.
Category
Treatment - Drugs
2
Description
Control group: Using 15 ml of normal saline, every 12 hours, for 4 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi hospital
Full name of responsible person
Mirbastegan Nasrin
Street address
Namazi hospital, Zand street, Namazi squer
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Shahid Beheshti university of medical sciences
Full name of responsible person
Dr Zarghi
Street address
Side of Ayatollah Taleghani hospital. shaheid Aarbi street. Yaman street. Shahied CHamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahid Beheshti 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
Shahid Beheshti university of medical sciences
Full name of responsible person
Nasrin Mirbastegan
Position
Master of critical care nursing
Other areas of specialty/work
Street address
Opposite to Rajaee Heart Hospital, Cross of Valiasr and Neiaiesh Highway,Valiasr street
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
mirbastegan.nasrin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery Shahid Beheshti university of medical sciences
Full name of responsible person
Mehryar Yoldashkhan
Position
Master of anesthesia
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Cross of Valiasr and Neiaiesh Highway,Valiasr street
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
yoldashkhan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of nursing & midwifery Shahid Beheshti university of medical sciences
Full name of responsible person
Nasrin mirbastegan
Position
master of critical care nursing
Other areas of specialty/work
Street address
Opposite to Rajaee Heart Hospital, Cross of Valias and Neiaiesh Highway,Valiasr street,school of nursing & midwifery SHahid Beheshti
City
Tehran
Postal code
Phone
Fax
Email
Mirbastegan.nasrin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)