Evaluating Viola Odorata for Prevention of Mechanical Ventilation-Related Complications: The First Double Blind Randomized Clinical Trial

Abstract

Endotracheal intubation is a life-saving procedure performed to protect the airway. However, it may lead to significant complications such as edema, granuloma, and strictures. A unified approach for preventing these complications remains elusive. This study aims to compare the efficacy of Pulmicort plus salbutamol (S-P) versus Viola Odorata extract combined with salbutamol (S-V) in preventing intubation-related complications. This study aims to assess the use of Pulmicort combined with salbutamol versus Viola Odorata extract combined with salbutamol for the prevention of intubation-related complications. This randomized clinical trial was conducted on 63 patients under mechanical ventilation due to trauma from 2018 to 2020. Patients were randomly assigned to receive either 2.5 mg of salbutamol via nebulizer every six hours, plus two puffs of 0.5 mg Pulmicort spray, or 10 cc of Viola Odorata syrup twice daily. Ultrasonographic assessments of air leak, tracheal air column diameter, and tracheal wall thickness were performed at baseline and at the time of weaning. The two groups were similar in terms of age and gender distribution (P>0.05). Comparison of baseline and final measurements of tracheal air column diameter, tracheal wall thickness, and air leak revealed a significant increase in both groups (P<0.001). Post-weaning assessments revealed no significant differences between the S-P and S-V groups in any parameters (P>0.05), except for a higher tracheal air diameter in the S-P group (P=0.004). This study found that Viola Odorata extract led to promising outcomes in preventing mechanical ventilation-related complications. Comparisons with Pulmicort revealed no significant differences. These findings, achieved through ultrasonographic evaluations, suggest that Viola Odorata may be a viable alternative for preventing intubation-related complications. © 2025 Tehran University of Medical Sciences. All rights reserved.