Comparison of the intubation rate in bronchiolitis patients with nava and non-invasive ventilation versus patients with exclusive non-invasive ventilation: a multicentred, randomized clinical trial

Abstract

BACKGROUND: Acute RSV bronchiolitis is a lower respiratory tract infection. It is a common pathology, causing many admissions to the PICU every fall-winter season and high mortality worldwide. No effective treatment has been demonstrated for this

pathology, so the treatment nowadays is based on supportive therapy, such as non- invasive ventilation. The issue is that current machines do not detect well the air

volumes that infants under one year of age mobilize, causing patient-ventilator asynchrony. NAVA can reduce these asynchronies, improving the patient's symptoms.

OBJECTIVES: This clinical trial aims to analyse the intubation rate of children under 12 months with RSV+ bronchiolitis, comparing both the non-invasive ventilation system with NAVA and the exclusive non-invasive ventilation system without NAVA. The second objective is to compare the days of hospitalization in PICU.

DESIGN: Randomized, controlled, multicentred, open-label, prospective clinical trial. It will be performed among Catalan hospitals that have a PICU service.

PARTICIPANTS: Participants included in this study are infants under 12 months with RSV+ bronchiolitis, who are admitted to the PICU and need non-invasive ventilation. The sample size will be 522 patients, 261 in each group, who meet inclusion criteria.

METHODS: The primary dependent variable will be the intubation rate and the secondary, the length of hospitalization. We will include the following covariables: age, sex, weight, ethnicity, bacterial infection and history of prematurity. The patients will be randomized and assigned in two different groups: exclusive non-invasive ventilation and non-invasive ventilation with NAVA. We will follow-up these patients during their stay at the PICU, taking into account dependent variables and covariables. The results will be analyzed and compared in the two different groups