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IRCT20221119056537N1 IRCT 2023-08-10 Mashhad University of Medical Sciences Comparison of the effect of Thyme and Chlorhexidine glucosan mouthwash on oral health of ventilated patients in the intensive care unit Comparison of the effect of Thyme and Chlorhexidine glucosan mouthwash on oral health of ventilated patients in the intensive care unit 2023-09-05 anticipated 46 Complete https://irct.ir/trial/71558 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups at any time during the randomization and at certain points the number of participants in each group is equal. Then the list of blocks is written and numbers are assigned to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choosing random numbers between 1 to 6 (for example 1 4 5 and...) and finally defining the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-). In this design, the randomization unit is individual, Blinding description: 1) The study participants are blind due to their low level of consciousness and being intubated. 2) The researcher will only apply chlorhexidine and thyme mouthwash by numbering them and will not know the identity of each mouthwash. 3) Statistical analysts will also analyze the data through coding. 3 Intubated patients hospitalized in intensive care unite. Intervention 1: Intervention group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of thyme mouthwash will be administered three times a day (every eight hours) as a wet swab for five days. Intervention 2: Control group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of Chlorhexidine mouthwash will be administered three times a day (every eight hours) as a wet swab for five days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Haniyeh Samarghandi
Univercity street
Mashhad Iran (Islamic Republic of) ١٣٩۴۴ ٩١٣٨٨ +98 51 3859 1511 samarghandih992@mums.ac.ir Mashhad University of Medical Sciences scientific Haniyeh Samarghandi
University street
Mashhad Iran (Islamic Republic of) ١٣٩۴۴ ٩١٣٨٨ +98 51 3859 1511 samarghandih992@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1) Older than 18 years old 2) The patient needs mechanical ventilation at least for 48 hours 3) The airway used for the patient is a tracheal tube. 4) Not using an endotracheal tube before admission to the intensive care unit 5) Consent to participate in the study by the patient or guardian 6) Not having pneumonia during hospitalization in the intensive care unit 7) No history of allergy to herbal compounds 8) Not having an autoimmune disease or immune system deficiency 9) Absence of obvious lesions in and around the mouth upon admission Having a nasogastric tube for feeding 18 years no limit Both pregnancy extubation transfer from the intensive care unit to the ward or death of the patient J39 Other diseases of upper respiratory tract Other Other Intervention group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of thyme mouthwash will be administered three times a day (every eight hours) as a wet swab for five days. Control group: Before each intervention, the patient's position will be supine, and if not prohibited, the patient's head will be raised 30 degrees and turned to one side. Before using the mouthwash to prevent microaspiration, the tracheal tube cuff pressure will be measured once for both groups, and then the cuff stiffness method will be used for the next times to ensure the appropriate pressure of the cuff. Before the intervention, the entire surface of the mouth, gums and teeth will brushed with a soft toothbrush. For patients in the intervention group, five milliliters of Chlorhexidine mouthwash will be administered three times a day (every eight hours) as a wet swab for five days. Oral health score in oral health assessment questionnaire. Timepoint: Before the intervention, two and five days after using thyme and chlorhexidine mouthwash. Method of measurement: oral health assessment questionnaire. Mashhad University of Medical Sciences Approved 2023-05-29 Ethics committee of Mashhad University of Medical Sciences, School of Nursing and Midwifery University St., Doctor's Road, Faculty of Nursing and Midwife Mashhad Razavi Khorasan Iran (Islamic Republic of)