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IRCT20110427006318N13 IRCT 2020-10-11 Semnan University of Medical Sciences Effect of Clove extract mouthwash on incidence of Ventilator-Associated Pneumonia Effect of Clove extract mouthwash on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical care unit 2020-10-26 anticipated 10 Complete https://irct.ir/trial/51245 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research sample assigned to the groups of the study by permuted blocks randomization. The blocks will be AB or BA. A is the intervention group, B is the control group. After randomly selecting one of the two possible blocks, two consecutive samples are randomly placed in intervention or control group. Blocking is used within gender and age. Regarding to the age, the first patient is randomly placed in the intervention or control group, the next patient with maximum age difference of five years is placed in another group. If the next patient's age difference is more than five years, the patient is randomly placed in another age block. Regarding to the gender, randomization is done separately for men and women. In other words, the first female patient is randomly placed in the intervention or control group and next female patient is placed in another group. For the male patients division is done in the same way, Blinding description: In this study, mouthwashes will be prepared by the investigator and given blindly to the critical care unit nurse, who performed the mouthwash. Patients are not aware of the type of solution. The physician evaluating Ventilator-Associated Pneumonia and the statistician are blind to the study groups (intervention and control). 3 Ventilator-Associated Pneumonia. Intervention 1: Intervention group: In the intervention group, mouthwash by 15 ml of clove extract, with concentration 33% from 20% solution, prepared from Dr. Jahangir company, are doing twice a day in 8 am and 4 pm for 5 days. Intervention 2: Control group: In the control group, mouthwash by 15 ml of Chlorhexidine 0.2% solution, prepared from the donyaye behdasht company, are doing twice a day in 8 am and 4 pm for 5 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data is confidential
public Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences scientific Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) New patient admitted to the intensive care unit Age over 18 years Patients under mechanical ventilation for more than 48 hours No aspiration symptoms or pneumonia No infection with Covid-19 No contraindications to oral care No contraindication to elevation of head of bed at least 30 degrees Insensitivity to chlorhexidine 0.2% 18 years no limit Both Fever 38.5 and above during the first 24 hours after intubation Positive PCR test (infection of Covid-19) Re-intubation more than 3 times Apache II score above 30 j69.0 Pneumonitis due to food and vomit Prevention Prevention Intervention group: In the intervention group, mouthwash by 15 ml of clove extract, with concentration 33% from 20% solution, prepared from Dr. Jahangir company, are doing twice a day in 8 am and 4 pm for 5 days. Control group: In the control group, mouthwash by 15 ml of Chlorhexidine 0.2% solution, prepared from the donyaye behdasht company, are doing twice a day in 8 am and 4 pm for 5 days. Ventilator-Associated Pneumonia. Timepoint: 1th and 5th days. Method of measurement: The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure to inspired oxygen fraction and chest x ray diagnose pneumonia. Ventilator-Associated Pneumonia. Timepoint: 1th and 5th days. Method of measurement: The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure to inspired oxygen fraction and chest x ray diagnose pneumonia. Semnan University of Medical Sciences Approved 2020-09-22 Ethics committee of Semnan University of Medical science Semnan University of Medical Sciences, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of) Approved 2020-09-22 Ethics committee of Semnan University of Medical science Semnan University of Medical Sciences, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)