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IRCT20210523051370N4 IRCT 2021-10-12 Mazandaran University of Medical Sciences The effect of pomegranate peel extract on the prevention of ventilator-associated pneumonia 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 2021-11-22 anticipated 120 Complete https://irct.ir/trial/57627 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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, 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 description: The assessor will be blind to the random assignment of patients in the groups. N/A Ventilator-associated pneumonia. Intervention 1: 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. Intervention 2: 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. 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 All data will be kept confidential
public Dr Seyed Afshin Shorofi
Imam Square. Three_way Joibar. Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences scientific Dr Afshin Shorofi
Imam Square. Three_way Joibar. Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 J95.851 ventilator-associated pneumonia Prevention Prevention 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. 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. 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. Mazandaran University of Medical Sciences Approved 2021-06-08 Bioethics Committee of Mazandaran University of Medical Sciences Moalem Square, Sari, Mazandaran Province sari Mazandaran Iran (Islamic Republic of)