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IRCT20180110038298N1 IRCT 2018-02-23 Zahedan University of Medical Sciences Effect of oropharyngeal decontamination by topical antibiotics on the ventilator associated pneumonia Effect of oropharyngeal decontamination by topical antibiotics on incidence of ventilator-associated pneumonia in hospitalized traumatic patients in intensive care units 2018-02-04 anticipated 100 Complete https://irct.ir/trial/28891 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: At first, patients will be selected from eligible people with valid entry criteria and then assigned to two groups of intervention and control in a simple random manner. The randomization will be as follows: 100 cards (corresponding to the estimated sample size) are colored with green and orange colors. Green cards are assigned to the control group and 50 red cards for the intervention group. Cards are arranged randomly. After referring to the department and examining the patient and determining his eligibility, depending on the color of card is assigned to each patient, the control group or intervention is determined, Blinding description: Only researcher will be aware of the randomness. In order to blindness, a nurse familiar with critical care , after education about the method of mouthwash and the use of tools, recruitment as a partner who is not familiar with how to allocate patients in the intervention or control group. The solution is uniform and looks similar to the drug solution is provided and give to the nurse for the control group. Proficient collaborator and Samples analyzer lab will not be aware of the randomness. N/A Ventilator associated pneumonia. Intervention 1: Intervention group: On the first day of intubation, oral washing perform four times a day, with normal saline solution. On the second day of intubation, collect the initial sample of the pharyngeal and tracheal secretions and sent to the laboratory for culture, then with a 2% concentration of poly-myxin, nystatin and neomycin, prepared and combined by investigator administer with a syringe on the oral cavity and the lips are used in such a way that the mucus is impregnated with it. This action is repeated four times after normal oral saline mouthwash. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed. Intervention 2: Control group: On the first day of intubation, mouth washing is perform four times in day, with normal saline solution. On the second day, first sampled the tracheal and pharyngeal discharge, then, daily after each oral wash with normal saline, a solution with the appearance and volume of the same basic solution used by the researcher with a syringe in the mouth and lips, is applied in such a way that the mucosa is impregnated. This action is repeated four times. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed. 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 No more information
public Morteza Barani
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3344 2482 mimbaran@yahoo.com Zahedan University of Medical Sciences scientific Aliakbar Keykha
No. 1, Behdasht Blvd.,Mashahir square, Faculty of Nursing and Midwifery
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3344 2482 aliakbar.keykha@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) The age of the patient is between 18 and 65 years Perform intubation in the first 24 hours and stay at least 72 hours Clinical pulmonary infection score less than 6 at the time of arrival Oral hygiene assessment checklist score 10 or less GCS less than 9 18 years 65 years Both damage to the mouth, jaw and face cancer and diabetes and chronic obstructive pulmonary disease immunosuppression due to certain medications or diseases history of broad-based antibiotic therapy in the past 3 months perform a cardiopulmonary resuscitation process J95.851 Ventilator associated pneumonia Prevention Prevention Intervention group: On the first day of intubation, oral washing perform four times a day, with normal saline solution. On the second day of intubation, collect the initial sample of the pharyngeal and tracheal secretions and sent to the laboratory for culture, then with a 2% concentration of poly-myxin, nystatin and neomycin, prepared and combined by investigator administer with a syringe on the oral cavity and the lips are used in such a way that the mucus is impregnated with it. This action is repeated four times after normal oral saline mouthwash. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed. Control group: On the first day of intubation, mouth washing is perform four times in day, with normal saline solution. On the second day, first sampled the tracheal and pharyngeal discharge, then, daily after each oral wash with normal saline, a solution with the appearance and volume of the same basic solution used by the researcher with a syringe in the mouth and lips, is applied in such a way that the mucosa is impregnated. This action is repeated four times. The duration of the study is at least three days, and if the terms of exclusion are not established, it lasts for a maximum of five days. At the end of the fifth day, the throat and tracheal secretions are again sampled and the intervention is completed. The incidence of ventilator-dependent pneumonia. Timepoint: At the beginning of the study, before the intervention, and daily until the end of the intervention. Method of measurement: Clinical pulmonary infection score. Microorganisms grown from pharyngeal and tracheal secretion samples. Timepoint: The first day of the study before the intervention and 5. Method of measurement: Perform culturing in the laboratory by a laboratory collaborator. Zahedan University of Medical Sciences Approved 2017-12-24 Ethics committee of zahedan university of medical Sciences NO. 1 , Daneshgah Ave., Hesabi Squ., Pardis complex , university of medical sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)