The comparative effects of mouthwash containing pomegranate peel extract (Punica granatum) and chlorhexidin 0.2% on the prevention of ventilator associated pneumonia in patients admitted to intensive care units
To examine the effects of mouthwash containing pomegranate peel extract (punica granatum) and chlorhexidin 0.2% on the prevention of ventilator associated pneumonia in patients admitted to intensive care units
Design
This is a single blind randomized controlled clinical trial. A total of 120 eligible patients will be selected based on convenience sampling. The researchers will allocate them to experimental and control groups using block randomization.
Settings and conduct
This is a single blind RCT (an assessor blind trial) in which a total of 120 patients to be admitted to ICUs will be selected based on convenience sampling method. The researchers will allocate them to experimental and control groups using block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients aged 18-65 years
having a tracheal tube
up to 12 hours to elapse after ICU admission
Exclusion criteria:
tracheostomy tube
reintubation
Intervention groups
In the experimental group, the nurse will apply 20 CC of 5% pomegranate peel extract mouthwash twice a day using a syringe. Then, she cleanses the teeth, tongue, gum, and oral mucosa and simultaneously suctions the mouth and pharynx for 30 seconds. Finally, she moisturizes the lips with A+D moisturizing cream. If there is an airway, she will remove and clean it and put it back in the mouth.
In the control group, the nurse will apply 10 CC of 0.2% chlorhexidine mouthwash solution twice a day on the teeth, tongue, gum, and oral mucosa and simultaneously suctions the mouth and pharynx for 30 minutes.
Main outcome variables
Pneumonia severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N4
Registration date:2021-10-12, 1400/07/20
Registration timing:prospective
Last update:2021-10-12, 1400/07/20
Update count:0
Registration date
2021-10-12, 1400/07/20
Registrant information
Name
Seyed Afshin Shorofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ashorofi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effects of mouthwash containing pomegranate peel extract (Punica granatum) and chlorhexidin 0.2% on the prevention of ventilator associated pneumonia in patients admitted to intensive care units
Public title
The effect of pomegranate peel extract on the prevention of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 years
Having a tracheal tube
Up to 12 hours to elapse after ICU admission
Not affected by immune system disorders or lung diseases, including pneumonia, asthma, and allergic rhinitis
Having natural teeth
Not simultaneously participating in other interventional studies
Exclusion criteria:
Patients with tracheostomy tube
A history of taking antibiotics during the last two weeks
A history of allergy to chlorhexidine and herbal mouthwashes
Reintubation
Severe maxillofacial trauma
Pregnant and lactating patients
A history of malignancy and cancer
A history of head and neck radiotherapy
A history of oral mucositis and periodontal diseases
Patients with sepsis and COVID-19 in admission
Patients with COVID-19 in admission
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 120 eligible patients will be selected based on convenience sampling. The researchers will allocate them to experimental (A) and control groups (B) using block randomization. When the block size is four, there are six possible sequences of letter placement (i.e., AABB1-ABBA2-BABA3-BBAA4-BABA5-ABAB6). Then, using Random Allocation Software 2.0, one of the numbers from one to six is randomly selected thirty times. Each number determines four modes of placement in a block. The blocks of four participants are randomly placed in 30 opaque envelopes and arranged based on their numbers. A person who is not a member of the research team and is unaware of the research objectives and the participant’s allocation in the study groups will seal the envelopes. The researcher will open the envelopes in order and assign the patients to the relevant groups. The assessor will also be blind to the random assignment of patients in the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blind to the random assignment of patients in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
We will only take chest X-rays (CXR) for patients suspected of having pneumonia. An assessor with intensive care subspecialty will interpret the CXRs. Oral care and using mouthwash (0.2% chlorhexidine for the control group and pomegranate peel extract mouthwash for the experimental group) will be performed twice a day (every 12 hours) for five consecutive days. The assessor will check and record the Clinical Pulmonary Infection Score (CPIS) of all patients on the first, third, and fifth days. A dentist has adequately trained the nurse who applies the mouthwash and checks the patients' oral condition.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Sari, Mazandaran Province
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-06-08, 1400/03/18
Ethics committee reference number
IR.MAZUMS.REC.1400.234
Health conditions studied
1
Description of health condition studied
Ventilator-associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
ventilator-associated pneumonia
Primary outcomes
1
Description
Clinical Pulmonary Infection Score. According to the CPIS, a score of 6 or higher indicates mechanical ventilator-associated pneumonia.
Timepoint
The assessor will check and record the Clinical Pulmonary Infection Score of all patients on first, third and fifth days.
Method of measurement
Pulmonary of Infection Survey Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Before using mouthwash, the pneumonia is assessed using the Clinical Pulmonary Infection Score (CPIS). To apply the mouthwash in the experimental and control groups, the researcher will prepare the required equipment at the patient's bedside. It includes suction, suction tip, Nelaton Catheter FG 14, toothpaste, toothbrush, moisturizing cream, 0.9% normal saline, 5 CC syringe, gloves, pomegranate peel extract mouthwash, scissors, bandage, and regular gauze. Then, the ICU nurse (someone other than the researchers) washes her hands, wears gloves, puts one centimeter of fluoride Signal toothpaste on a soft toothbrush, and brushes all the surfaces of the teeth (i.e., buccal, lingual/palatal, and the gum surfaces) with rotating along with up-down movements for 2 minutes. Then, she cleanses the surface of the teeth and mouth with 5 CC of 0.9% normal saline and simultaneously suctions it for 30 seconds. In the experimental group, the nurse, who is trained how to brush teeth and how to use chlorhexidine and pomegranate peel extract mouthwashes, will apply 20 CC of 5% pomegranate peel extract mouthwash twice a day using a syringe. Then, she cleanses the teeth, tongue, gum, and oral mucosa and simultaneously suctions the mouth and pharynx for 30 seconds.
Category
Prevention
2
Description
To apply the mouthwash in the control groups, the researchers will prepare the required equipment at the patient's bedside. It includes suction, suction tip, Nelaton Catheter FG 14, toothpaste, toothbrush, moisturizing cream, 0.9% normal saline, 5 CC syringe, gloves, 0.2% chlorhexidine solution, scissors, bandage, and regular gauze. Then, the ICU nurse (someone other than the researchers) washes her hands, wears gloves, puts one centimeter of fluoride Signal toothpaste on a soft toothbrush, and brushes all the surfaces of the teeth (i.e., buccal, lingual/palatal, and the gum surfaces) with rotating along with up-down movements for 2 minutes. Then, she cleanses the surface of the teeth and mouth with 5 CC of 0.9% normal saline and simultaneously suctions it for 30 seconds. In the control group, the nurse will apply 10 CC of 0.2% chlorhexidine mouthwash solution twice a day on the teeth, tongue, gums, and oral mucosa and simultaneously suctions the mouth and pharynx for 30 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Seyed Afshin Shorofi
Street address
Imam Khomeini Hospital. Amir Mazandarani Street. Sari
City
Sari
Province
Mazandaran
Postal code
33131 48166
Phone
+98 11 3337 7178
Email
ashorofi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Majid Saeedi
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeed@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Square. Three_way Joibar. Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Square. Three_way Joibar. Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam square. Three way Joibar. Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available