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IRCT20201121049455N1 IRCT 2020-12-10 Zahedan University of Medical Sciences Study of the effect of comprehensive oral care program and combination of toothbrush and mouthwash with chlorhexidine 0.2% on the incidence of ventilator-associated pneumonia and oral health status in patients undergoing mechanical ventilation. Comparison the effect of comprehensive oral care program and combination of toothbrush and mouthwash with chlorhexidine 0.2% on the incidence of ventilator-associated pneumonia and oral health status in patients undergoing mechanical ventilation 2020-09-07 anticipated 90 Complete https://irct.ir/trial/52459 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using permutation blocks, patients were assigned to three groups: comprehensive oral care program, combined toothbrush and mouthwash program, and control. Considering that three groups were considered in the study, patients were divided into fifteen cases of six blocks, A group of comprehensive oral care program and B group of toothbrush and mouthwash and C control group (for example: (AABBCC, ABABCC, BBAACC,…). There were two people in each block from each group. The order of the blocks was determined randomly using a random number table and then the patients entered the comprehensive care, toothbrush, mouthwash and control group based on the blocks, Blinding description: The ambiguity of the study was that the anesthesiologist interpreting the chest X-ray, which is part of the MCPIS instrument, did not know the patients in the three groups and confirmed the presence or absence of infiltration without knowing which group the patient was in. . Also, the person conducting the oral health assessment has no information about the patients' inclusion in the study groups. N/A Ventilator associated pneumonia. Intervention 1: Intervention group: Comprehensive Oral Care Plan: The Comprehensive Oral Care Plan was designed based on previous studies and included performing the following 5 minutes of oral care each time: Washing hands and wearing gloves, controlling cuff tube pressure in Less than 25 mm Hg, raising the head of the bed by 30 to 45 degrees, brushing the inner and outer surfaces of the teeth, gums and tongue for 2 minutes using a baby toothbrush and toothpaste with rotating movements, deep throat and mouth suction. For 30 seconds while 0.9% normal saline is poured into the patient's mouth and on the teeth, rinse the mouth with 0.2% chlorhexidine antibacterial solution with a swab, moisten all surfaces of the patient's oral mucosa, gums and tongue using a swab. And use vitamin A + D to lubricate the lips. If there was an oral pharyngeal airway, it was removed, cleaned and repositioned in the patient's mouth. Intervention 2: Intervention group: Combined program of toothbrush and mouthwash with chlorhexidine 0.2%: The intervention was performed during 5 days of study for 5 minutes each time of oral care. With a baby toothbrush and antimicrobial toothpaste containing half a centimeter of fluoride, all the outer and inner surfaces of the teeth and gums were gently brushed with rotating movements. The teeth, tongue surfaces, and palate were then brushed back and forth. After brushing, each part of the mouth was cleaned with sterile distilled water, so that the applicator was soaked with sterile distilled water and rinsed and cleaned with that mouth. The mouth, tongue, and teeth were then flushed with a swab soaked in chlorhexidine solution. The control group received routine oral care. Intervention 3: Control group: Mouthwash with chlorhexidine. 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 It is not clear yet and will be announced later.
public Fariba Yaghobinia
Nursing & Midwifery school, Mashahir square
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3343 0059 yaghoubinia@gmail.com Zahedan University of Medical Sciences scientific Fariba Yaghoubinia
Nursing & Midwifery school, Mashahir square
Zahedan Iran (Islamic Republic of) 9816913396 +98 54 3343 0059 yaghoubinia@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Age range 65-18 years On the second day of the patient's hospitalization Achieve a score less than or equal to 5 of the MCPIS criteria No severe damage to face and mouth No chronic disease and defective immune system No movable dentures The patient is not pregnant Normal coagulation status 18 years 65 years Both Performing a tracheostomy procedure during the study Removal or replacement of endotracheal tube during the study Detach from mechanical ventilation before 96 hours Clearance from the ward Allergy to chlorhexidine Reluctance to continue the study by the legal guardian Patient death Evidence of signs and symptoms of aspiration after the start ofthe study according to the patient file j15.6 Pneumonia due to other Gram-negative bacteria Prevention Prevention Prevention Intervention group: Comprehensive Oral Care Plan: The Comprehensive Oral Care Plan was designed based on previous studies and included performing the following 5 minutes of oral care each time: Washing hands and wearing gloves, controlling cuff tube pressure in Less than 25 mm Hg, raising the head of the bed by 30 to 45 degrees, brushing the inner and outer surfaces of the teeth, gums and tongue for 2 minutes using a baby toothbrush and toothpaste with rotating movements, deep throat and mouth suction. For 30 seconds while 0.9% normal saline is poured into the patient's mouth and on the teeth, rinse the mouth with 0.2% chlorhexidine antibacterial solution with a swab, moisten all surfaces of the patient's oral mucosa, gums and tongue using a swab. And use vitamin A + D to lubricate the lips. If there was an oral pharyngeal airway, it was removed, cleaned and repositioned in the patient's mouth. Intervention group: Combined program of toothbrush and mouthwash with chlorhexidine 0.2%: The intervention was performed during 5 days of study for 5 minutes each time of oral care. With a baby toothbrush and antimicrobial toothpaste containing half a centimeter of fluoride, all the outer and inner surfaces of the teeth and gums were gently brushed with rotating movements. The teeth, tongue surfaces, and palate were then brushed back and forth. After brushing, each part of the mouth was cleaned with sterile distilled water, so that the applicator was soaked with sterile distilled water and rinsed and cleaned with that mouth. The mouth, tongue, and teeth were then flushed with a swab soaked in chlorhexidine solution. The control group received routine oral care. Control group: Mouthwash with chlorhexidine Ventilator-dependent pneumonia score. Timepoint: Ventilator-dependent pneumonia score before intervention and end of fifth day. Method of measurement: Clinically modified pneumonia scale. Oral health status. Timepoint: Beck oral assessment scale score during five days of study. Method of measurement: Beck Oral Assessment Scale. Zahedan University of Medical Sciences Approved 2020-09-07 Ethics Committee of Zahedan University of Medical Sciences Zahedan University of Medical Sciences,Dr. Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)