Comparative Study of The Effect of Botanical Extract Mouthwashes of Tea Tree Oil/Aloe vera and Chlorhexidine on Prevention of Ventilator-Associated Pneumonia in Admitted Patients in Intensive Care Unites
Determining and comparing the effect of mouthwash containing tea tree oil/aloe vera extract and chlorhexidine on prevention of early and late ventilator-associated pneumonia in intubated patients hospitalized in intensive care units
Design
A clinical double-blind trial, with parallel groups, randomized by simple randomization method, with the participation of 62 intubated patients
Settings and conduct
This study is conducted in hospitals affiliated to Arak University of Medical Sciences and in intensive care units. Oral care in the intervention group was performed using tea tree oil/aloe vera mouthwash and in the control group using chlorhexidine 0.2%. Patients Due to the lack of consciousness and awareness as well as nurses and caregivers are unaware of the placement of people in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
•The presence of a endotracheal tube
• Age 16 to 65 years
•Mechanical ventilation for at least 72 hours
•Absence of pulmonary infection based on the modified clinical pulmonary infection score (scoring less than 5 at the time of entering the study)
•Absence of allergy to herbal compounds of tea tree oil or aloe vera
Criteria for not entering the study:
•Traumatization during intubation
•Transferring the patient from ICU or his death
•Extubation of the patient for any reason
• Unwillingness of the patient's companions to continue the study
•Observing side effects caused by mouthwash
•Sudden changes in the patient's clinical condition or breathing pattern
Intervention groups
Oral care in intervention group will be performed using mouthwash containing tea tree oil/aloe vera extract and in control group by using 0.2% chlorhexidine mouthwash. The method, time, frequency of mouthwash is done in the same way in both groups.
Main outcome variables
ventilator-associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210104049936N1
Registration date:2022-08-14, 1401/05/23
Registration timing:prospective
Last update:2022-08-14, 1401/05/23
Update count:0
Registration date
2022-08-14, 1401/05/23
Registrant information
Name
Parisa Mohseni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 0287
Email address
parisamohseni@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-16, 1401/05/25
Expected recruitment end date
2022-11-16, 1401/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of The Effect of Botanical Extract Mouthwashes of Tea Tree Oil/Aloe vera and Chlorhexidine on Prevention of Ventilator-Associated Pneumonia in Admitted Patients in Intensive Care Unites
Public title
Comparative Study of The Effect of Botanical Extract Mouthwashes of Tea Tree Oil/Aloe vera and Chlorhexidine on Prevention of Ventilator-Associated Pneumonia in Admitted Patients in Intensive Care Unites
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
To have oral endotracheal tube
Age between 16 to 65
Being at least 72 hours ventilated
Absence of pulmonary infection based on the modified pulmonary infection clinical score (score less than 5 at the time of study entry)
Absence of history of allergy to herbal compounds of tea tree oil or aloe vera (based on the history obtained from the legal guardian or the patient's companion)
Absence of specific oral lesions or infections
Absence of sepsis, pulmonary thromboembolism, absence of history and signs of aspiration, absence of orthodontics, atelectasis, inflammatory gastrointestinal or bile ducts diseases and severe liver diseases according to the diagnosis of a specialist doctor (based on physical examination and history obtained from the legal guardian or with the patient).
Exclusion criteria:
Traumatization during intubation
Transferring patient from the ICU (for any reason) or death before completing the study
Patient extubation for any reason
Withdrawal or unwillingness of the legal guardian of the patient to continue the study
Observing side effects caused by using mouthwash such as hives, itching and skin rashes
Sudden changes in the patient's clinical condition or breathing pattern
The presence of defects in the patient's immune system
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method. At first, preferably two hospitals or two general intensive care units with similar care protocols are divided into two groups: A and B. Then envelopes will assigned to each, another person randomly chooses the envelopes and according to the classification, one of the units (hospitals) will be the intervention group and the other will be the control group. Then, based on the inclusion criteria, the researcher will enter the patients in each group and the intervention will be carried out for that group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the lack of consciousness and awareness, the patients are not aware of being placed in the intervention or control group. Mouthwash bottles are also covered before distribution and coded by a person who does not participate in the study. The researcher, his colleagues (nurses or caregivers) and the doctor who determines the final result of the study will not know about the placement of people in the intervention or control group. Therefore the principle of double-blindness of the study is maintained.
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
13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamak and Zarafshan Ave,. Quds town (west), Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.062
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
Ventilator-Associated Pneumonia
Timepoint
Assessing the presence or absence of ventilator-associated pneumonia upon entering the study (before the start of the intervention), day 3 (to diagnose early ventilator-associated pneumonia) and day 7 (to diagnose late ventilator-associated pneumonia) after the intervention
Method of measurement
The diagnosis of ventilator-associated pneumonia in this research will be done using the Modified Clinical Pulmonary Infection Score (MCPIS). This tool includes five laboratory and a score of 0-2 is considered for each criterion and the maximum score is 10. If the sum of scores is equal to or more than 6, pneumonia is diagnosed.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before performing oral care, hands are washed according to the instructions and gloves are worn, and the oral cavity is evaluated. If there is a lesion, the doctor will be informed and if other treatments are needed, appropriate measures will be taken according to the doctor's order. Cuff pressure is adjusted to ensure proper fit using a special manometer (20-30 cm of water). The position of all patients in this study will be semi-sitting with an angle of 30-45 degrees if there are no contraindications. Then, twice a day (every 12 hours), all areas of the mouth, including the inner and outer surfaces of the teeth (with rotating movements), gums and tongue (with movements from back to front) are brushed with a soft toothbrush. Before and after brushing each part of the mouth, tea tree oil/aloe vera mouthwash is poured in the same part with a special syringe and suctioned in less than 30 seconds. Closed suctioning of subglottic secretions is also performed, and if the patient has an airway, it is removed, cleaned and put back in the mouth. At the end, the modified clinical pulmonary infection score is given to each patient 72 hours (to evaluate the incidence of early VAP) and 7 days (to evaluate the incidence of late VAP) after the intervention. Mouthwash containing tea tree oil extract/aloe vera is named Irsha and produced by Shafa Pharmaceutical and Health Laboratory. It is supplied in 250 ml bottles and are used twice a day in the amount of 15 ml each time.
Category
Prevention
2
Description
Control group: Before performing oral care, hands are washed according to the instructions and gloves are worn, and the oral cavity is evaluated. If there is a lesion, the doctor will be informed and if other treatments are needed, appropriate measures will be taken according to the doctor's order. Cuff pressure is adjusted to ensure proper fit using a special manometer (20-30 cm of water). The position of all patients in this study will be semi-sitting with an angle of 30-45 degrees if there are no contraindications. Then, twice a day (every 12 hours), all areas of the mouth, including the inner and outer surfaces of the teeth (with rotating movements), gums and tongue (with movements from back to front) are brushed with a soft toothbrush. Before and after brushing each part of the mouth, the 0/2% chlorhexidine mouthwash is poured in the same part with a special syringe and suctioned in less than 30 seconds. Closed suctioning of subglottic secretions is also performed, and if the patient has an airway, it is removed, cleaned and put back in the mouth. At the end, the modified clinical pulmonary infection score is given to each patient 72 hours (to evaluate the incidence of early VAP) and 7 days (to evaluate the incidence of late VAP) after the intervention. 0.2% chlorhexidine solution is manufactured by Shahr Daru Company, which is used in the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated to Arak University of Medical Sciences