title: Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov website ( NCT01730794 ). Registered on 15 November 2012.
authors.affiliation: CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Monforte de Lemos 3-5, Pabellon 11, 28029, Madrid, Spain. jesus.villar54@gmail.com.|Multidisciplinary Organ Dysfunction Evaluation Research Network, Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 4th Floor-South Wing, 35019, Las Palmas de Gran Canaria, Spain. jesus.villar54@gmail.com.|Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada. jesus.villar54@gmail.com.
authors.forename: Jesús
authors.initials: J
authors.lastname: Villar
authors.affiliation: Department of Anesthesiology, Hospital Clínico Universitario de Valencia, Avda. Blasco Ibañez 17, 46010, Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Belda
authors.affiliation: CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Monforte de Lemos 3-5, Pabellon 11, 28029, Madrid, Spain.|Intensive Care Unit, Hospital Universitario Río Hortega, Calle Dulzaina, 2, 47012, Valladolid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Blanco
authors.affiliation: CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Monforte de Lemos 3-5, Pabellon 11, 28029, Madrid, Spain.|Hedenstierna Laboratory, Department of Surgical Sciences, Uppsala University Hospital, Akademiska Sjukhuset, Ing 40, Tr 3, SE-75185, Uppsala, Sweden.
authors.forename: Fernando
authors.initials: F
authors.lastname: Suarez-Sipmann
authors.affiliation: Intensive Care Unit, Hospital Virgen de La Luz, Hermandad de Donantes de Sangre s/n, 16002, Cuenca, Spain.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Añón
authors.affiliation: CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Monforte de Lemos 3-5, Pabellon 11, 28029, Madrid, Spain.|Division of Clinical Epidemiology and Biostatistics, Research Unit, Hospital Universitario NS de Candelaria, Carretera General del Rosario 145, 38010, Santa Cruz de Tenerife, Spain.
authors.forename: Lina
authors.initials: L
authors.lastname: Pérez-Méndez
authors.affiliation: Department of Anesthesiology, Hospital Clínico Universitario de Valencia, Avda. Blasco Ibañez 17, 46010, Valencia, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Ferrando
authors.affiliation: Intensive Care Unit, Hospital Universitario NS de Candelaria, Carretera General del Rosario 145, 38010, Santa Cruz de Tenerife, Spain.
authors.forename: Dácil
authors.initials: D
authors.lastname: Parrilla
authors.affiliation: Intensive Care Unit, Hospital Universitario NS de Candelaria, Carretera General del Rosario 145, 38010, Santa Cruz de Tenerife, Spain.
authors.forename: Raquel
authors.initials: R
authors.lastname: Montiel
authors.affiliation: Intensive Care Unit, Hospital General NS del Prado, Carretera de Madrid, Km. 114, 45600, Talavera de la Reina, Toledo, Spain.
authors.forename: Ruth
authors.initials: R
authors.lastname: Corpas
authors.affiliation: Intensive Care Unit, Hospital Virgen de La Luz, Hermandad de Donantes de Sangre s/n, 16002, Cuenca, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: González-Higueras
authors.affiliation: Department of Anesthesiology, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km. 9,100, 28034, Madrid, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Pestaña
authors.affiliation: Intensive Care Unit, Hospital Universitario Virgen de la Arrixaca, Carretera Madrid-Cartagena s/n, 30120, El Palmar, Murcia, Spain.
authors.forename: Domingo
authors.initials: D
authors.lastname: Martínez
authors.affiliation: Intensive Care Unit, Hospital Universitario Río Hortega, Calle Dulzaina, 2, 47012, Valladolid, Spain.
authors.forename: Lorena
authors.initials: L
authors.lastname: Fernández
authors.affiliation: Department of Anesthesiology, Hospital Clínico Universitario de Valencia, Avda. Blasco Ibañez 17, 46010, Valencia, Spain.
authors.forename: Marina
authors.initials: M
authors.lastname: Soro
authors.affiliation: Division of Biostatistics, Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 35019, Las Palmas de Gran Canaria, Spain.
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: García-Bello
authors.affiliation: CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Monforte de Lemos 3-5, Pabellon 11, 28029, Madrid, Spain.|Multidisciplinary Organ Dysfunction Evaluation Research Network, Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 4th Floor-South Wing, 35019, Las Palmas de Gran Canaria, Spain.
authors.forename: Rosa Lidia
authors.initials: RL
authors.lastname: Fernández
authors.affiliation: Department of Respiratory Care, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.|Department of Anesthesiology, Harvard University, 55 Fruit Street Gray-Bigelow 444, Boston, MA, 02144, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Kacmarek
mesh_terms: D000208:Acute Disease; D002985:Clinical Protocols; D017052:Hospital Mortality; D006801:Humans; D059725:Interactive Ventilatory Support / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D007902:Length of Stay; D008168:Lung / Q000294:innervation*; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D012125:Respiratory Center / Q000503:physiopathology*; D012131:Respiratory Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D015656:Respiratory Mechanics; D012307:Risk Factors; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D015300:Ventilator Weaning
keywords: Acute respiratory failure; Assist ventilation; Liberation from mechanical ventilation; Lung-protective ventilation; Neurally adjusted ventilatory assist; Ventilator-free days