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
| Autor: | Saló Fradera, Ariadna |
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| Přispěvatelé: | Universitat de Girona. Facultat de Medicina, Sánchez Fernández, Mario, Puig i Miquel, Teresa |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | Medicina (TFG) DUGiDocs – Universitat de Girona instname |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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