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Study aim
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comparison between budesonide and salbutamol vs viola odorata and salbutamol in airway inflammation reduction.
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Design
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Clinical trial with two intervention groups, double-blind, randomized, phase 2-3 was performed on 60 patients. Randomized block method was used for randomization.
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Settings and conduct
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Intubated trauma patients admitted to the ICU of Al-Zahra Hospital in Isfahan were studied. On the first day, the seventh day and the fourteenth day, the diameter of the air column between the endotracheal tube and the tracheal wall, the thickness of tracheal wall is measured by ultrasound. The difference in expiratory air volume is measured by the ventilator while the endotracheal tube cuff is full and empty. The patient and the doctor doing the ultrasound are blinded
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Participants/Inclusion and exclusion criteria
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inclusion criteria: age between 18 - 65 years, admission due to trauma, intubation lasts at least 24 hours, patient is intubated during past 2 weeks exclusion criteria: discontinuation of therapy for any reason (extubation befor trial ends, drugs side effects, patient or his/her family dissatisfaction, ... ), history of previous intubation airway anomalies, history of lung disease, history of Inhaled corticosteroid or systemic corticosteroid usage in past month, administration of systemic corticosteroid in current admition, hemodynamic instability, history of smoking 25 cigarettes per day or more
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Intervention groups
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patients are divided in two groups. one group receives salbutamol nebulizer 2.5 mg four times per day and viola odorata syrup 10 cc three times per day and second group receives salbutamol nebulizer 2.5 mg four times per day and pulmicort nebulizer 0.5 mg two times per day.
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Main outcome variables
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The diameter of the air column between the endotracheal tube and the tracheal wall- tracheal wall thickness- The volume of air leaked around the endotracheal tube