POST-MARKET CLINICAL FOLLOW-UP SURVEY OF THE ELECTRIC NASAL ASPIRATOR: A EVALUATION OF PERFORMANCE AND SAFETY

Abstract

Background: Due to the inflammation, children with bronchiolitis suffer from hypoxia, difficulty feeding and respiratory distress. Most patients can be easily managed at home, but some require additional interventions such as supplemental oxygen, frequent nasal suctioning, intravenous (IV) fluids, and/or nasogastric tube feeds. Post-market clinical follow-up (PMCF) studies are essential for verifying the real-world safety and performance of the Electric nasal aspirator(model:BC026). The study was aimed at testing if cleaning the nasal cavities of children with recurrent wheezing using an electric nasal aspirator improves the upper and lower respiratory symptoms in routine clinical practice. Methods: A prospective, observational, single-center study was conducted at Guangzhou Xinshi Hospital, China. In this randomized controlled pilot study, we compared two separate nasal suction devices, namely the over counter device by the brand name of NoseFrida and the Electric nasal aspirator(model:BC026), in hospitalized children with bronchiolitis to assess equivalence of length of stay within a ± 5-h equivalence margin and to compare respiratory symptoms including sneezing, cough and so on. Additionally, parental satisfaction for the the electric nasal aspirator(model:BC026) was measured with a four question survey. A total of 100 cases (50 cases, 50 controls) completed the study. Parents of wheezing children (age 2-12 years) answered questionnaires and learned using a Manual nasal aspirator (50 cases) and using an electric nasal aspirator (model:BC026) (50 controls). Results: The electric nasal aspirator(model:BC026) demonstrated non-inferiority to the brand name of NoseFrida in performance and safety, supporting its continued use in diverse clinical applications. Serious Adverse Events: No device-related adverse events occurred. Customer Satisfaction: 90% of parents/ caregivers agreed this nose suction device is easy to use, 94% agreed I am comfortable using this nose suction device, 94% agreed this nose suction device is effective to clear my children's nose, 86% agreed that I am satisfied with this nose suction device.