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Comparison of the effect of botanical extract mouthwashes of meswak/aloe vera and chlorhexidine on prevention of ventilator-associated pneumonia in ventilated patient

Protocol summary

Study aim
The effect of mouthwash containing toothbrush / aloe vera wood extract and chlorhexidine solution on ventilator-induced pneumonia in patients with inpatient chip tubes in intensive care units is compared.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. For randomization, the necessary software for permutation blocks is used
Settings and conduct
Intubated patients admitted to the intensive care units of Vali-e-Asr Teaching Hospital in Arak are randomly divided into two groups. Oral care and rinsing in patients in the intervention group using mouthwash containing toothbrush extract / aloe vera, and in patients in the control group using chlorhexidine mouthwash 0.2%.
Participants/Inclusion and exclusion criteria
Entry criteria: the presence of a chip tube through the mouth, age 16 to 65 years, artificial ventilation for at least 72 hours, the absence of pulmonary infection , lack of sensitivity to plant compounds, absence of sepsis, pulmonary embolism, Atherosclerosis, inflammatory diseases of the gastrointestinal tract, bile ducts and severe liver disease Criteria for leaving the study: Transfer of the patient from the ICU or his death before completing the study, the reluctance of the patient's companions to continue the study, observation of complications from using mouthwash such as urticaria, itching and skin rash, sudden changes in The patient's clinical condition or respiratory pattern, the presence of a defect in the patient's immune system
Intervention groups
Oral care and washing is performed in patients of the intervention group using mouthwash containing toothbrush / aloe vera wood extract, and in patients in the control group using chlorhexidine mouthwash 0.2%.
Main outcome variables
Comparison of ventilator-induced pneumonia in patients of the intervention and control group.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161014030294N4
Registration date: 2020-09-09, 1399/06/19
Registration timing: registered_while_recruiting

Last update: 2020-09-09, 1399/06/19
Update count: 0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Mansoreh Karimikia
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 4702
Email address
m.karimikia@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of botanical extract mouthwashes of meswak/aloe vera and chlorhexidine on prevention of ventilator-associated pneumonia in ventilated patient
Public title
Comparison of the effect of botanical extract mouthwashes of meswak/aloe vera and chlorhexidine on prevention of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of endotracheal tube through the mouth Age 16 to 65 years Mechanical ventilation for at least 72 hours Absence of lung infection based on the clinical score of the modified lung infection Lack of sensitivity to plant compounds Absence of sepsis Absence of pulmonary thromboembolism Absence of atelectasis Absence of inflammatory diseases of the gastrointestinal tract Absence of severe liver and bile duct diseases
Exclusion criteria:
Transfer the patient from the ICU or die before completing the study Reluctance of the patient's companions to continue the study Observe the side effects of using mouthwash such as hives, itching and skin rashes Sudden changes in the patient's clinical condition or respiratory pattern occur Existence of defects in the patient's immune system
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done purposefully. We perform permutation block randomization method with statistical software. We considered four blocks for two mouthwashes. The possibility of predicting the type of treatment for the researcher is reduced.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into two groups in the form of permutation blocks. Patients and caregivers and nurses responsible for collecting data are unaware of the type of mouthwash used. Mouthwashes are used in the same container and labeled A and B so that they are not identifiable in terms of the type of mouthwash.Patients do not notice the difference in the taste of mouthwash due to intubation and anesthesia
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2019-06-08, 1398/03/18
Ethics committee reference number
IR.ARAKMU.REC.1398.082

Health conditions studied

1

Description of health condition studied
Ventilator-associated pneumonia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The rate of ventilator-induced pneumonia
Timepoint
72 hours and 7 days after the intervention and when the patient is extubated.
Method of measurement
Microbiological tests of lung secretions

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mouthwash containing toothbrush wood extract / Aloe vera produced by Barij Essential Oil Company is used. 5 ml of mouthwash is poured into different parts of the mouth using a syringe and immediately sucked. This operation is performed every 8 hours by the nurse for 14 days. The lung secretion culture test is performed on the third, seventh and fourteenth day.
Category
Prevention

2

Description
Control group: Mouthwash containing 0.2% chlorhexidine is used. 5 ml of mouthwash is poured into different parts of the mouth using a syringe and immediately sucked. This operation is performed every 8 hours by the nurse for 14 days. The lung secretion culture test is performed on the third, seventh and fourteenth day.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital in Arak
Full name of responsible person
Behnam Mahmoudieh
Street address
Vali Asr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2004
Fax
+98 86 3223 1283
Email
Behnammahmoudye@yahoo.com‬

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
a.kamali@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimi Kia
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
karimikia93@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Behnam Mahmoudieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
Behnammahmoudye@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimi Kia
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
karimikia93@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 2 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use documentation by citing the source
From where data/document is obtainable
Mansoreh Karimi Kia Arak University of Medical Sciences Phone 09181600717 Email karimikia93@gmail.com
What processes are involved for a request to access data/document
After receiving the request by phone or email, the data will be sent within 2 weeks.
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