Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial
| Autor: | Elena González-Higueras, Lorena Fernández, Domingo Martínez, Robert M. Kacmarek, Carlos Ferrando, Marina Soro, Ruth Corpas, Jesús Villar, Javier Belda, Miguel A. García-Bello, Dácil Parrilla, Jesús Blanco, Rosa Lidia Fernández, Fernando Suarez-Sipmann, Lina Pérez-Méndez, Raquel Montiel, David Pestaña, José M. Añón |
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| Jazyk: | angličtina |
| Předmět: |
Time Factors
medicine.medical_treatment Respiratory Medicine and Allergy Medicine (miscellaneous) Acute respiratory failure Ventilator-free days law.invention Study Protocol 0302 clinical medicine Primary outcome Randomized controlled trial Clinical Protocols law Risk Factors Neurally adjusted ventilatory assist Pharmacology (medical) Hospital Mortality Prospective Studies Interactive Ventilatory Support Lung Lung function Lungmedicin och allergi Respiratory center Treatment Outcome Research Design Anesthesia Acute Disease Respiratory Insufficiency Ventilator Weaning Anestesi och intensivvård Liberation from mechanical ventilation 03 medical and health sciences medicine Humans In patient Mechanical ventilation Anesthesiology and Intensive Care business.industry Kirurgi Assist ventilation Lung-protective ventilation 030208 emergency & critical care medicine Recovery of Function Length of Stay Respiratory Center 030228 respiratory system Spain Respiratory Mechanics Surgery business |
| Zdroj: | Trials Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-016-1625-5 |
| Popis: | Background Patient-ventilator asynchrony is a common problem in mechanically ventilated patients with acute respiratory failure. It is assumed that asynchronies worsen lung function and prolong the duration of mechanical ventilation (MV). Neurally Adjusted Ventilatory Assist (NAVA) is a novel approach to MV based on neural respiratory center output that is able to trigger, cycle, and regulate the ventilatory cycle. We hypothesized that the use of NAVA compared to conventional lung-protective MV will result in a reduction of the duration of MV. It is further hypothesized that NAVA compared to conventional lung-protective MV will result in a decrease in the length of ICU and hospital stay, and mortality. Methods/design This is a prospective, multicenter, randomized controlled trial in 306 mechanically ventilated patients with acute respiratory failure from several etiologies. Only patients ventilated for less than 5 days, and who are expected to require prolonged MV for an additional 72 h or more and are able to breathe spontaneously, will be considered for enrollment. Eligible patients will be randomly allocated to two ventilatory arms: (1) conventional lung-protective MV (n = 153) and conventional lung-protective MV with NAVA (n = 153). Primary outcome is the number of ventilator-free days, defined as days alive and free from MV at day 28 after endotracheal intubation. Secondary outcomes are total length of MV, and ICU and hospital mortality. Discussion This is the first randomized clinical trial examining, on a multicenter scale, the beneficial effects of NAVA in reducing the dependency on MV of patients with acute respiratory failure. Trial registration ClinicalTrials.gov website (NCT01730794). Registered on 15 November 2012. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1625-5) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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