Comparison of the effect of Myrtus herbal mouthwash versus chlorhexidine mouthwash on the prevention of Ventilator Associated Pneumonia in ICU patients
Design
randomized, blinded, clinical trial with a parallel group design of 70 patients
Settings and conduct
70 patients with endotracheal tubes in the intensive care units of Ghaem Hospital in Mashhad, who have the criteria to enter the study, are evaluated and compared in the stages before the intervention and in the fifth day by using the Clinical Pulmonary Infection Scale.
Participants/Inclusion and exclusion criteria
The main caregiver of the patient should be consciously satisfied to participate in the research (due to the disorder in the patient's level of consciousness), The patient's age should be between 70-18 years, Immunosuppressive diseases and underlying lung disease are not recognized by the treating physician, Do not have a specific lesion in or around the mouth, Has no history of allergy to herbal ingredients (according to the history obtained from the patient's primary caregiver), Under mechanical ventilation through the endotracheal tube, At the time of hospitalization in the ICU and intubation, there is no evidence of pneumonia in chest radiography at the discretion of the treating physician, Must be mechanically ventilated for at least the next 48 hours (according to the definition of Ventilator Associated Pneumonia).
Intervention groups
The herbal mouthwash used in the intervention group and chlorhexidine mouthwash 0.2% in the control group for 5 days and three times a day by the same method are used by researcher. Other care will be the same in both groups.
Main outcome variables
prevention of Ventilator Associated Pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200705048006N1
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Ali Farahmandnasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
farahmandna961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Myrtus herbal mouthwash versus chlorhexidine mouthwash on the prevention of Ventilator Associated Pneumonia
Public title
Comparison of the effect of Myrtus herbal mouthwash versus chlorhexidine mouthwash on the prevention of Ventilator Associated Pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The main caregiver of the patient should be consciously satisfied to participate in the research (due to the disorder in the patient's level of consciousness)
The patient's age should be between 70-18 years
Immunosuppressive diseases and underlying lung disease are not recognized by the treating physician
Do not have a specific lesion in or around the mouth
Has no history of allergy to herbal ingredients (according to the history obtained from the patient's primary caregiver)
Under mechanical ventilation through the endotracheal tube
At the time of hospitalization in the ICU and intubation, there is no evidence of pneumonia in chest radiography at the discretion of the treating physician
Must be mechanically ventilated for at least the next 48 hours (according to the definition of Ventilator Associated Pneumonia)
Exclusion criteria:
Withdrawal of the patient's primary caregiver from continuing the study
Transfer or death of the patient, removal of the endotracheal tube before 48 hours
Allergic reaction to mouthwash
Observation of obvious aspiration (observation of gastric material during endotracheal tube suction, change of position, cough, etc.)
Do not have an upper airway infection (based on your doctor's diagnosis)
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random sequence generated by SPSS software that is written on small cards and kept in an envelope in a package. After confirming the entry of each research unit into the study, the envelope is opened and based on the entered code, the patient enters one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
- Participants in this study are unconscious patients and their primary caregiver is unaware of the type of mouthwash used for them. Therefore, the patient's primary caregiver is blind to the intervention.
- After data collection by one researcher, statistical analysis will be performed by another person who does not know the type of intervention and data related to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibn Sina Avenue, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-07-06, 1399/04/16
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.015
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system:pneumonia
Primary outcomes
1
Description
prevention of Ventilator Associated Pneumonia
Timepoint
Before the intervention and the fifth day after the intervention
Method of measurement
Clinical Pulmonary Infection Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives oral care with the herbal mouthwash for 5 days and three times a day by the same method by the researcher. Other care will be the same in both groups.This mouthwash is a leaf extract of the plant with a concentration of 5%, which will be prepared and calibrated by the Faculty of Traditional and Complementary Medicine.
Category
Treatment - Drugs
2
Description
Control group: Oral care with chlorhexidine mouthwash 0.2% of the construction of Iran Najo Pharmaceutical Factory, which will be poured in 30 cc, will be received by the researcher in the same way for 5 days and three times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان قائم (عج) مشهد
Full name of responsible person
علی فرهمند نسب
Street address
مشهد، میدان دکتر علی شریعتی، ابتدای خیابان احمدآباد
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
FarahmandNA961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
محسن تفقدی
Street address
خیابان دانشگاه، رو به روی خیابان دانشگاه 18، معاونت پژوهش و فناوری دانشگاه
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Farahmand Nasab
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FarahmandNA961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
علی فرهمند نسب
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FarahmandNA961@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Farahmand Nasab
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FarahmandNA961@mums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
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
6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for other human research and health centers
From where data/document is obtainable
Library of Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
By visiting the library of Mashhad School of Nursing and Midwifery in person or online