]>
IRCT20230611058449N1 IRCT 2023-06-27 Shahid Beheshti University of Medical Sciences Effect of probiotic prophylaxis on ventilator-associated pneumonia Effect of probiotic prophylaxis on the prevention of ventilator-associated pneumonia (VAP) in patients admitted to the intensive care unit (ICU) 2023-06-19 anticipated 134 Complete https://irct.ir/trial/70632 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method in this study will be systematic random sampling .For each patient in the first group, we will have one patient in the second group. The determination of the people of the first and second groups will be based on the last digit of the patient's admission code. In this way, the first patient whose last digit of their code is odd is placed in the intervention group, and vice versa, the first patient whose last digit of their code is even is placed in the control group, Blinding description: The patient does not know which group is the study or the control group, the control group will receive standard treatments along with placebo capsules that look similar to the original capsules produced by Tekgen Biot. The number of drugs, the nurse who prescribes the drug, the examining doctor and the doctor who registers the vital signs do not know about the patient group. 3 Ventilator associated pneumonia. Intervention 1: Intervention group: Patients over 18 years of age and intubated with mechanical ventilation randomly placed in the intervention group of this study will use BioIBS probiotic capsules produced by Tekgen Biot Company, each capsule containing 5 x 10 to the power of 9 Lactobacillus Casei, Lactobacillus Rhamnosus, Lactobacillus Acidophilus . The prescribed dosage of probiotics will be one capsule every 12 hours for 15 days. They will also receive other standard treatments to prevent ventilator-associated pneumonia , which include position of the head and upper body at an angle of 30 degrees; Oral hygiene of the patient with chlorhexidine mouthwash; Cessation of sedation during daily periods and waking the patient up; Daily periods of spontaneous breathing of the patient. Intervention 2: Control group: Patients over 18 years of age and intubated and connected to mechanical ventilation were randomly placed in the control group of this study and will receive standard treatments along with placebo capsules that look similar to the original capsules produced by Tekgen Biot. Standard treatments to prevent They will also receive ventilator-related lung infection, which include: position of the head and upper body at an angle of 30 degrees, oral hygiene of the patient with chlorhexidine mouthwash, interruption of sedation during daily periods and waking up the patient, daily periods of spontaneous breathing of the patient. 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 There is no further information
public Ali Nazembokaee
Darabad ; Shahid Bahonar Street
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 ali_nb@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ali Nazembokaee
Darabad ; Shahid Bahonar Street
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 ali_nb@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients over the age of 18 that are intubated in the intensive care unit 18 years no limit Both Diagnosis was ventilator-associated pneumonia from beginning Diagnosis was pneumonia from beginning Pregnancy Prosthetic heart valves Prosthetic vascular grafts Immunosuppress History of rheumatic fever History of gastrointestinal tract injury in the current hospitalization Having tracheostomy Lack of consent of the patient or her or his parents Gavage intolerance J95.851 Ventilator associated pneumonia Treatment - Drugs Treatment - Drugs Intervention group: Patients over 18 years of age and intubated with mechanical ventilation randomly placed in the intervention group of this study will use BioIBS probiotic capsules produced by Tekgen Biot Company, each capsule containing 5 x 10 to the power of 9 Lactobacillus Casei, Lactobacillus Rhamnosus, Lactobacillus Acidophilus . The prescribed dosage of probiotics will be one capsule every 12 hours for 15 days. They will also receive other standard treatments to prevent ventilator-associated pneumonia , which include position of the head and upper body at an angle of 30 degrees; Oral hygiene of the patient with chlorhexidine mouthwash; Cessation of sedation during daily periods and waking the patient up; Daily periods of spontaneous breathing of the patient. Control group: Patients over 18 years of age and intubated and connected to mechanical ventilation were randomly placed in the control group of this study and will receive standard treatments along with placebo capsules that look similar to the original capsules produced by Tekgen Biot. Standard treatments to prevent They will also receive ventilator-related lung infection, which include: position of the head and upper body at an angle of 30 degrees, oral hygiene of the patient with chlorhexidine mouthwash, interruption of sedation during daily periods and waking up the patient, daily periods of spontaneous breathing of the patient. Clinical Pulmonary Infection Score. Timepoint: Clinical Pulmonary Infection Score at the beginning of the study and the third day after probiotic consumption. Method of measurement: Clinical Pulmonary Infection Score using ; body temperature ; leukocyte count and morphology , tracheal secretion volume and character , PaO2/FiO2 values , presence of pulmonary infiltration ; Tracheal aspirate culture. Shahid Beheshti University of Medical Sciences Approved 2023-05-27 Ethics committee in medical school research Sixth floor ; 2nd Building ; Shahid Beheshti University of Medical Sciences ; Arabi street ; Yemen Street ; Shahid Chamran Highway ; Tehran Tehran Tehran Iran (Islamic Republic of)