Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial
2016 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, 500Article in journal (Refereed) Published
Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ Dr Negrin, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Res Unit, Barranco Ballena S-N,4th Floor South Wing, Las Palmas Gran Canaria 35019, Spain.;St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr Biomed Sci, 30 Bond St, Toronto, ON M5B 1W8, Canada..
Hosp Clin Univ Valencia, Dept Anesthesiol, Avda Blasco Ibanez 17, Valencia 46010, Spain..
Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ Rio Hortega, Intens Care Unit, Calle Dulzaina 2, Valladolid 47012, Spain..
Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Univ Uppsala Hosp, Hedenstierna Lab, Dept Surg Sci, Akad Sjukhuset, Ing 40,Tr 3, SE-75185 Uppsala, Sweden..
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.
Place, publisher, year, edition, pages
2016. Vol. 17, 500
Acute respiratory failure, Neurally adjusted ventilatory assist, Ventilator-free days, Lung-protective ventilation, Assist ventilation, Liberation from mechanical ventilation
Surgery Respiratory Medicine and Allergy
IdentifiersURN: urn:nbn:se:uu:diva-307539DOI: 10.1186/s13063-016-1625-5ISI: 000385434800006PubMedID: 27737690OAI: oai:DiVA.org:uu-307539DiVA: diva2:1047324