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IRCT20220204053931N2 IRCT 2022-05-11 Kerman University of Medical Sciences The effect of Trachyspermum Ammi syrup on the prevention of ventilator-associated pneumonia The effect of Trachyspermum Ammi syrup on the prevention of ventilator-associated pneumonia in mechanically ventilated patients in the trauma intensive care units 2022-05-15 anticipated 60 Complete https://irct.ir/trial/63229 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method will be used to allocate samples to the control and intervention groups. The single sequence of random numbers will be generated using Excel software. Sequences of random numbers in sealed envelopes will be provided to the researcher responsible for the intervention. Patients who have inclusion criteria and no exclusion criteria will be randomly assigned to the intervention or control group based on the sequences, Blinding description: In this study, due to placebo use, patients, the researcher performing the intervention, the physician evaluating the outcome of the intervention (VAP), and the researcher conducting the statistical analysis; will not know which patients are in the control group and which are in the intervention group. 1 Ventilator associated pneumonia. Intervention 1: Intervention group: Gavage of Trachyspermum Ammi syrup 10%, from the first day of enteral feeding, 10 ml, three times a day for ten days. Intervention 2: Control group: gavage of placebo syrup (containing all the basic ingredients of the syrup without adding Trachyspermum Ammi ), from the first day of enteral feeding, 10 ml, three times a day for ten days. Yes - There is a plan to make this available What will be shared: All of the individual participant data collected during the trial, after deidentification. When: Six months after the results will be published, the data will be available for 24 months. In special situations, the access period will be extended To whom: Researchers working in universities, scientific institutes and industry Conditions: To conduct research Where to obtain: Contact the following email: f_razban@kmu.ac.ir How to obtain: After reviewing the request by the research team and with the approval of the Vice-Chancellor for Research of Kerman University of Medical Sciences Comments:
public Dr. Mehdi Ahmadinejad
Qarani street, Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mehdia50@gmail.com Kerman University of Medical Sciences scientific Dr. Mehdi Ahmadinejad
Shahid Bahonar Hospital, Qarani street
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mehdia50@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Having an oral endotracheal tube Receiving mechanical ventilation ICU hospitalization due to trauma 18 years 65 years Both Having pneumonia at the time of admission Cardiopulmonary diseases Lung contusion Pulmonary thromboembolism Atelectasis Inflammatory diseases Digestive diseases Liver and biliary diseases History of allergies to herbal drugs Symptoms of pulmonary aspiration Weak immune system Substance abuse and addiction Extubation before 10 days Death or ICU discharge before 10 days Sudden change in hemodynamic status Complications such as hives, itching and skin rashes that can be a sign of allergy to Trachyspermum Ammi syrup J09-J18 Influenza and pneumonia Treatment - Drugs Treatment - Drugs Intervention group: Gavage of Trachyspermum Ammi syrup 10%, from the first day of enteral feeding, 10 ml, three times a day for ten days Control group: gavage of placebo syrup (containing all the basic ingredients of the syrup without adding Trachyspermum Ammi ), from the first day of enteral feeding, 10 ml, three times a day for ten days Ventilator-associated pneumonia. Timepoint: Ventilator-associated pneumonia will be assessed on the fifth and tenth day of the intervention. Method of measurement: Ventilator-associated pneumonia will be assessed by an infectious disease specialist using the Clinical Lung Infection Scale (CPIS). CPIS includes six criteria, including temperature, white blood cell count, tracheal secretion, oxygenation, culture and smear of tracheal secretion, and chest x-ray. Each of criteria is given a score of zero to two. The maximum score of this tool is 10. VAP is diagnosed if the sum of scores is equal to or greater than 6. Kerman University of Medical Sciences Approved 2022-04-16 Ethics committee of Kerman University of Medical Sciences Afzalipour hospital, Imam Khomeini highway Kerman Kerman Iran (Islamic Republic of)