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IRCT2017060711399N5 IRCT 2017-06-26 Vice chancellor for research, Semnan University of Medical Sciences The Effect of Hyssop Essence and Chlorhexidine Gluconate on Oral Hygiene Comparing the Effect of Hyssop Essence and Chlorhexidine Gluconate Mouthwashes on Oral Hygiene in Intubated Patients in Intensive Care Unit 2017-06-30 anticipated 90 Complete https://irct.ir/trial/11675 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Samples will be randomly selected among one unit of intensive care units of Sari Emam Khomaini hospital. N/A Oral Hygiene in Intubated Patients. Intervention 1: In the experimental group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25 cmh2o by the help of pressure manometer .Then half of Hyssop mouthwash solution 0.02% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days. Intervention 2: In the control group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Chlorhexidine Gluconate mouthwash solution 0.2% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days. Intervention 3: In the placebo group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Normal Saline mouthwash solution 0.9% (7.5 cc) is sprinkled to different parts of the patient's mouth . Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days.
public Mehrooz Alishah
1th floor, School of Nursing and Allied Health Sciences, Semnan University of Medical Sciences, 5th Km of Damghan Road
Semnan Iran (Islamic Republic of) +98 23 3365 4192 Alishahmehrooz@gmail.com Semnan University of Medical Sciences scientific Abbasali Ebrahimian
Room #120, 1th floor, School of Nursing an1th floor, School of Nursing and Allied Health Sciences, Semnan University of Medical Sciences, 5th Km of Damghan Road
Semnan Iran (Islamic Republic of) +98 23 3365 4191 aa.ebrahimian@semums.ac.ir; ebrahimian.aa@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age over 18 years; The Glasgow Coma Scale less than 8; The patient is intubated and received mechanical ventilation during the study; Non-antibiotic therapy over two weeks before hospitalization; Admission to ICU is past less than 12 hours; No history of allergy to the plants of the mint family (based on evidence of the statements of the patient's family); Having natural teeth; No history of radiation therapy; Having a Naso-Gastric Tube and no feeding by mouth. Exclusion criteria: History of radiation therapy; Diabetes; Jaw and facial injuries; Pregnant women; Using of immunosuppressive drugs such as Corticosteroids; History of seizures. 18 years 100 years Both K13.7 Other and unspecified lesions of oral mucosa Prevention Prevention Placebo In the experimental group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25 cmh2o by the help of pressure manometer .Then half of Hyssop mouthwash solution 0.02% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days. In the control group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Chlorhexidine Gluconate mouthwash solution 0.2% (7.5 cc) is sprinkled to different parts of the patient's mouth. Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days. In the placebo group, after washing hands, the bed head is elevated 30-45 degree. After wearing sterile gloves, the pressure of cuff in the tracheal tube is regulated in the range of 20-25cmH2O by the help of pressure manometer .Then half of Normal Saline mouthwash solution 0.9% (7.5 cc) is sprinkled to different parts of the patient's mouth . Internal and external surface of the upper and lower teeth, sides and surface of tongue are cleaned with a soft pediatric toothbrush. After the brushing procedure, the other half mouthwash solution (7.5 cc) will be sprayed to different parts of the mouth. After that, the remained solution in the mouth will be suctioned using a sterile catheter in less than 30 seconds. Oral wash will be done for patients during 30 seconds, twice a day (8 am and 4 pm), for 4 days. Oral Hygiene. Timepoint: Primery day, then daily until 4 day. Method of measurement: Check list of oral health assessment. Duration of stay in the intensive care unit. Timepoint: Daily. Method of measurement: Questionnaire. Vice chancellor for research, Semnan University of Medical Sciences Approved 2017-05-21 Ethic committee of Semnan University Of Medical Sciences Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd Semnan Iran (Islamic Republic of)