Abstract
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.
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Details
1 Instituto de Salud Carlos III, CIBER de Enfermedades Respiratorias, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000000093141427); Hospital Universitario Dr. Negrín, Multidisciplinary Organ Dysfunction Evaluation Research Network, Research Unit, Las Palmas de Gran Canaria, Spain (GRID:grid.411250.3) (ISNI:0000000403997109); St. Michael’s Hospital, Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, Toronto, Canada (GRID:grid.415502.7)
2 Hospital Clínico Universitario de Valencia, Department of Anesthesiology, Valencia, Spain (GRID:grid.411308.f)
3 Instituto de Salud Carlos III, CIBER de Enfermedades Respiratorias, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000000093141427); Hospital Universitario Río Hortega, Intensive Care Unit, Valladolid, Spain (GRID:grid.411280.e) (ISNI:0000000118423755)
4 Instituto de Salud Carlos III, CIBER de Enfermedades Respiratorias, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000000093141427); Uppsala University Hospital, Hedenstierna Laboratory, Department of Surgical Sciences, Uppsala, Sweden (GRID:grid.412354.5) (ISNI:0000000123513333)
5 Hospital Virgen de La Luz, Intensive Care Unit, Cuenca, Spain (GRID:grid.413507.4) (ISNI:0000000417657383)
6 Instituto de Salud Carlos III, CIBER de Enfermedades Respiratorias, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000000093141427); Hospital Universitario NS de Candelaria, Division of Clinical Epidemiology and Biostatistics, Research Unit, Santa Cruz de Tenerife, Spain (GRID:grid.411331.5) (ISNI:0000 0004 1771 1220)
7 Hospital Universitario NS de Candelaria, Intensive Care Unit, Santa Cruz de Tenerife, Spain (GRID:grid.411331.5) (ISNI:0000 0004 1771 1220)
8 Hospital General NS del Prado, Intensive Care Unit, Talavera de la Reina, Spain (GRID:grid.411331.5)
9 Hospital Universitario Ramón y Cajal, Department of Anesthesiology, Madrid, Spain (GRID:grid.411347.4) (ISNI:0000000092485770)
10 Hospital Universitario Virgen de la Arrixaca, Intensive Care Unit, El Palmar, Spain (GRID:grid.411372.2) (ISNI:0000000105343000)
11 Hospital Universitario Río Hortega, Intensive Care Unit, Valladolid, Spain (GRID:grid.411280.e) (ISNI:0000000118423755)
12 Hospital Universitario Dr. Negrín, Division of Biostatistics, Research Unit, Las Palmas de Gran Canaria, Spain (GRID:grid.411250.3) (ISNI:0000000403997109)
13 Instituto de Salud Carlos III, CIBER de Enfermedades Respiratorias, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000000093141427); Hospital Universitario Dr. Negrín, Multidisciplinary Organ Dysfunction Evaluation Research Network, Research Unit, Las Palmas de Gran Canaria, Spain (GRID:grid.411250.3) (ISNI:0000000403997109)
14 Massachusetts General Hospital, Department of Respiratory Care, Boston, USA (GRID:grid.32224.35) (ISNI:0000000403869924); Harvard University, Department of Anesthesiology, Boston, USA (GRID:grid.38142.3c) (ISNI:000000041936754X)