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IRCT20210523051370N6 IRCT 2022-05-21 Mazandaran University of Medical Sciences The effect of mouthwash containing Zataria multiflora essence 2% on the prevention of ventilator-associated pneumonia The comparative effects of the mouthwash containing Zataria multiflora essence 2% and chlorhexidine 0.2% on the prevention of ventilator-associated pneumonia in patients admitted to intensive care units 2022-06-05 anticipated 120 Complete https://irct.ir/trial/63153 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. Mouthwash (chlorhexidine 0.2% for the control group; chlorhexidine 0.2% + Zataria multiflora essence mouthwash 2% for the experimental group) will be administered 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. The nurse who applies the mouthwash checks the patient's oral condition, Randomization description: A total of 120 eligible patients are selected based on convenience sampling and will then be randomly allocated to either the experimental (A) or control group (B) using permuted block randomization. When the block size is four, there are six possible sequences of letter placement (i.e., AABB1-ABBA2-BABA3-BBAA4-BABA5-ABAB6). 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. To ensure the concealment of the sequence of enrolment, we will use the sequentially numbered, opaque sealed envelopes (undertaken by a person unaware of the study objectives and group allocations). Each envelop will contain the group assignment for four patients. The assessor will be blind to treatment allocation, Blinding description: To ensure the concealment of the sequence of enrolment, we will use the sequentially numbered, opaque sealed envelopes (undertaken by a person unaware of the study objectives and group allocations). The outcome assessor will also be blind to the random assignment of patients to the groups. N/A Ventilator-associated pneumonia. Intervention 1: Intervention group: The patient is assessed for pneumonia using the Clinical Pulmonary Infection Score (CPIS) before the mouthwash is administered. All the tooth surfaces and gum are cleaned using a soft bristled toothbrush and toothpaste for 2 minutes. The teeth and mouth are then cleaned with 5 CC of 0.9% normal saline and oral suction is simultaneously performed for 30 seconds. Chlorhexidine 0.2 (10 cc) is then used to rinse the mouth for one minute twice a day. Thereafter oral suction is done for 30 seconds. Finally, the mouthwash containing Zataria multiflora essence 2% (10 cc) will be applied twice a day for one minute and oral suction is then performed for 30 seconds. Intervention 2: Control group: The nurse will apply 10 CC of chlorhexidine 0.2% twice a day for five consecutive days. No - There is not a plan to make this available Justification or reason for not sharing IPD is All data will be kept confidential
public Dr Seyed Afshin Shorofi
Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences scientific Dr Afshin Shorofi
Mazandaran University of Medical Sciences, Valie-Asr Boulevard, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 18-65 years Having a tracheal tube <12 hours elapsed since ICU admission Having natural teeth 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 Cervical spine immobilization Pregnant and lactating women A history of malignancy and cancer A history of head and neck radiotherapy A history of oral mucositis and periodontal diseases Patients diagnosed with sepsis Patients with immune system disorders Patients with lung diseases (including pneumonia, asthma, and allergic rhinitis) Simultaneously participating in other interventional studies Patients with COVID-19 in admission Withdrawal criteria: patient death; patients transferred to the ward or other hospitals; reintubation; side effects associated with the use of either mouthwash; oral mucositis and periodontal diseases; sepsis; unwillingness to continue participation in the study; eligibility criteria violated J95.851 ventilator-associated pneumonia Prevention Prevention Intervention group: The patient is assessed for pneumonia using the Clinical Pulmonary Infection Score (CPIS) before the mouthwash is administered. All the tooth surfaces and gum are cleaned using a soft bristled toothbrush and toothpaste for 2 minutes. The teeth and mouth are then cleaned with 5 CC of 0.9% normal saline and oral suction is simultaneously performed for 30 seconds. Chlorhexidine 0.2 (10 cc) is then used to rinse the mouth for one minute twice a day. Thereafter oral suction is done for 30 seconds. Finally, the mouthwash containing Zataria multiflora essence 2% (10 cc) will be applied twice a day for one minute and oral suction is then performed for 30 seconds. Control group: The nurse will apply 10 CC of chlorhexidine 0.2% twice a day for five consecutive days. Clinical Pulmonary Infection Score. Timepoint: Clinical Pulmonary Infection Score on first, third and fifth days of mouthwash use. Method of measurement: Pulmonary of Infection Survey Questionnaire. Mazandaran University of Medical Sciences Approved 2022-03-30 Bioethics Committee of Mazandaran University of Medical Sciences Moalem Square, Sari, Mazandaran Province Sari Mazandaran Iraq