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IRCT20210104049936N1 IRCT 2022-08-14 Shahid Beheshti University of Medical Sciences 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 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 2022-08-16 anticipated 62 Complete https://irct.ir/trial/64701 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A Ventilator-Associated Pneumonia. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Parisa Mohseni
Milad J Block, 14 Ghadir St., Al-Ghadir Quarter
Arak Iran (Islamic Republic of) 3816993833 00988633670287, 00988632268807 parisamohseni074@gmail.com Shahid Beheshti University of Medical Sciences scientific Ladan Sedighi
Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, Niayesh Junc, Wali Asr St., Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 l.sedighie@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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). 16 years 65 years Both 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 J95.851 Ventilator associated pneumonia Prevention Prevention 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2022-06-21 Ethics committee of Shahid Beheshti University of Medical Sciences 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 Tehran Tehran Iran (Islamic Republic of)