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IRCT20080901001174N13 IRCT 2021-02-16 Deputy of Research and Technology of Guilan University of Medical Sciences The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units The effect of Probiotic capsule on Ventilator-Associated Pneumonia in patients hospitalized in Intensive Care Units of Poursina teaching remedial hospital of Rasht 2021-04-10 anticipated 92 Complete https://irct.ir/trial/54005 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization based on block permutation is used for randomization. To hide the allocation, block sizes are also randomly selected (4, 6). If the patient leaves the study, the relevant patient code will be assigned to the new sample. The site https://www.sealedenvelope.com/, which was set up to randomize clinical trials, will be used to generate a random allocation sequence, Blinding description: Study subjects are blind to the study intervention due to lack of knowledge about the type of drug (gavage as well as placebo or main drug). In the blinding of the evaluators, the ICU physician will not know about the randomization and the patient group to check the chest image and the final diagnosis of VAP, nor will the coordinator and data collector (student) know about the patient group. The project supervisor is responsible for blinding other researchers and they will have access to all the information. The student and Statistics specialist, who is in charge of the final analysis of the project, are not aware of the type of intervention of the defined groups (probiotics or placebo) in SPSS software. The sample allocator to the groups is the student implementing the project. Due to the use of placebo in the project, the student who conducting the project will not be aware of the type of intervention performed in the groups. To hide the allocation, the size of the blocks is randomly selected (4, 6). 3 Ventilator-Associated Pneumonia. Intervention 1: Intervention group: The subjects in the probiotic group receive Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) along with routine nursing care to prevent VAP. Each capsule Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) contains ten to the power nine clones probiotic bacteria consisting of Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus plantarum, Lactobacillus Gsry, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium Breve, Bifidobacterium longum and Streptococcus thermophilus along with fructooligosaccharide (FOS) are used as prebiotics. The above capsule is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel. Intervention 2: Control group: Patients in the control group receive a placebo capsule made by Zist-Takhmir Company along with routine VAP nursing care. The placebo capsule (manufactured by Zist-Takhmir Pharmaceutical Company) contains starch, which is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel. Yes - There is a plan to make this available What will be shared: Main and total Data When: After publication the results, the access period begins To whom: Universities and scientific institutions Conditions: In case of citing the article and observing the principles of intellectual property Where to obtain: Executor of proposal How to obtain: Contact with proposal executor and making ethical agreement Comments:
public Atefeh Ghanbari
Faculty of Nursing and Midwifery., Daneshjo St., shahid Beheshti highway.
Rasht Iran (Islamic Republic of) 4146939841 +98 13 3355 5056 at_ghanbari@gums.ac.ir Guilan University of Medical Sciences scientific Atefeh Ghanbari
Faculty of Nursing and Midwifery., Daneshjo St., shahid Beheshti highway.
Rasht Iran (Islamic Republic of) 4146939841 +98 13 3355 5056 at_ghanbari@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) Written informed consent from the client's family or guardian Age 18 years and older Under mechanical ventilation for more than 48 hours Not more than 48 hours have passed since the intubated 18 years no limit Both Pregnancy at the time of admission Multiple organ dysfunction History of Pneumonia Having chronic pulmonary disease Having immunosuppression diseases Immunosuppressive drug usage Stomach, esophagus and intestines damage Airway injury J95.8 Other postprocedural respiratory disorders Treatment - Drugs Placebo Intervention group: The subjects in the probiotic group receive Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) along with routine nursing care to prevent VAP. Each capsule Lactocare (manufactured by Zist-Takhmir Pharmaceutical Company) contains ten to the power nine clones probiotic bacteria consisting of Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus plantarum, Lactobacillus Gsry, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium Breve, Bifidobacterium longum and Streptococcus thermophilus along with fructooligosaccharide (FOS) are used as prebiotics. The above capsule is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel. Control group: Patients in the control group receive a placebo capsule made by Zist-Takhmir Company along with routine VAP nursing care. The placebo capsule (manufactured by Zist-Takhmir Pharmaceutical Company) contains starch, which is administered to patients by gavage separately from the patient's diet formula with 20 cc of water, twice a day for a maximum of two weeks. Routine care for VAP prevention in this study includes mouthwash with chlorhexidine solution 4 times a day, raising the head and trunk 30 degrees, sterile suction if necessary, endotracheal tube cuff pressure control, standard nutritional gavage through nasopharyngeal tube. Prevention of gastric ulcer by using Stomach acid inhibitor and prevention of Deep Vein Thrombosis and hand hygiene by personnel. The incidence of Ventilator-Associated Pneumonia. Timepoint: All patients in both probiotic and placebo groups are monitored daily. Patients are monitored for Ventilator-Associated Pneumonia for up to 14 days after intubation and initiation of probiotic or placebo. Method of measurement: The American College of Chest Physicians and ICD-10 criteria will be used to diagnose Ventilator-Associated Pneumonia in intubated patients admitted to intensive care units. These criteria; "Existence of new and continuous infiltration in the chest image with 2 or 3 cases: increase in temperature above 38.5 ° C or decrease in temperature below 35 ° C, increase in white blood cells above 12,000 per microliter, or a decrease in white blood cells to less than 3,000 per microliter, and purulent sputum are considered to indicate Ventilator-Associated Pneumonia. For microbiological diagnosis of ventilator-associated pneumonia, " Endotracheal Aspirate" culture will be used in a "quantitative" manner. In this method, a number of colonies above 100,000 is considered as a microbiological diagnosis of ventilator-dependent pneumonia. Duration of mechanical ventilation. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form. Duration of hospitalization in the Intensive Care Unit. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form. Mortality rate. Timepoint: It is checked daily by the researcher. Method of measurement: Researcher-made data collection form. Deputy of Research and Technology of Guilan University of Medical Sciences Approved 2021-01-27 Ethics Commitee of Guilan University Of Medical Science Deputy of Research and Technology of Guilan University of Medical Sciences., In front of 17Sharivar Hospital., Shahid Siadati St., Namjoo Blvd. Rasht Guilan Iran (Islamic Republic of)