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Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

ABSTRACT: PURPOSE:We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF). METHODS:We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for???5 days expected to require MV for???72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle. RESULTS:Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p?=?0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group difference - 5.2%, 95% CI - 15.2 to 4.8, p?=?0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups. CONCLUSION:NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF.

SUBMITTER: Kacmarek RM

PROVIDER: S-EPMC7474954 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

Kacmarek Robert M RM Villar Jesús J Parrilla Dácil D Alba Francisco F Solano Rosario R Liu Songqiao S Montiel Raquel R Rico-Feijoo Jesús J Vidal Anxela A Ferrando Carlos C Murcia Isabel I Corpas Ruth R González-Higueras Elena E Sun Qin Q Pinedo César E CE Pestaña David D Martínez Domingo D Aldecoa César C Añón José M JM Soro Marina M González-Martín Jesús M JM Fernández Cristina C Fernández Rosa L RL

Intensive care medicine 20200906 12

<h4>Purpose</h4>We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).<h4>Methods</h4>We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. ...[more]

PMID: 32893313

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Project description:IntroductionWe previously showed in animals that the ratio of inspired tidal volume (Vtinsp) to inspiratory peak electrical activity of the diaphragm (EAdipk) can be used to quantify the respective patient and ventilator breath contributions (PVBCs) during neurally adjusted ventilatory assist (NAVA). The PVBC index has not been tested clinically.MethodsWe studied 12 intubated and mechanically ventilated patients with acute respiratory failure and measured EAdipk, airway (Paw) and inspiratory esophageal pressure (Pes) and Vtinsp. We applied 11 different NAVA levels, increasing them every 3 minutes in steps of 0.3 cm H₂O/μV from 0 to 3.0 cmH₂O/μV. At each NAVA level, one breath was non-assisted (NAVA level 0). PVBC indices were calculated by relating Vtinsp/EAdipk of the non-assisted breath to Vtinsp/EAdipk of the assisted breath(s) using one ((N1)PVBC) or the mean value of five preceding assisted breaths ((X5)PVBC). During assisted breaths, inspiratory changes in Pes (∆Pes) and transpulmonary (ΔPtp) pressures were used to calculate the relative contribution of patient to total inspiratory lung-distending pressures (ΔPes/ΔPtp). Matching of respiratory drive indices and squaring of the PVBC was evaluated for their effect on the correlation between PVBC and ΔPes/ΔPtp. Linear regression analysis and Bland-Altman analysis were applied to compare indices.ResultsUsing an average of five assisted breaths prior to the non-assisted breath and squaring the PVBC ((X5)PVBC(2)) improved determination coefficients (P <0.05), adjusted the regression slope and intercept between PVBC and ΔPes/ΔPtp toward identity (P <0.05) and reduced bias (P <0.05). Matching EAdipk between non-assisted and assisted breaths within the range of 0.77 to 1.30 improved the relationship between (X5)PVBC(2) and ΔPes/ΔPtp (P <0.05) and abolished the need for EAdi normalization in the PVBC calculation (R(2) = 0.96; bias = 0.16 ± 0.06; precision = 0.33 ± 0.08 (mean and 95% confidence interval)).ConclusionsThis clinical study confirms previous experimental results showing that the PVBC(2) predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA, when differences in effort (EAdi) between non-assisted and assisted breaths are limited. PVBC could help to quantify and standardize the adjustment of the level of assist, and hence reduce the risks of excessive ventilatory assist in patients.Trial registrationClinicalTrials.gov NCT01663480. Registered 9 August 2012.

Project description:Assist in unison to the patient's inspiratory neural effort and feedback-controlled limitation of lung distension with neurally adjusted ventilatory assist (NAVA) may reduce the negative effects of mechanical ventilation on right ventricular function.Heart-lung interaction was evaluated in 10 intubated patients with impaired cardiac function using esophageal balloons, pulmonary artery catheters and echocardiography. Adequate NAVA level identified by a titration procedure to breathing pattern (NAVAal), 50% NAVAal, and 200% NAVAal and adequate pressure support (PSVal, defined clinically), 50% PSVal, and 150% PSVal were implemented at constant positive end-expiratory pressure for 20 minutes each.NAVAal was 3.1?±?1.1cmH2O/?V and PSVal was 17?±?2 cmH20. For all NAVA levels negative esophageal pressure deflections were observed during inspiration whereas this pattern was reversed during PSVal and PSVhigh. As compared to expiration, inspiratory right ventricular outflow tract velocity time integral (surrogating stroke volume) was 103?±?4%, 109?±?5%, and 100?±?4% for NAVAlow, NAVAal, and NAVAhigh and 101?±?3%, 89?±?6%, and 83?±?9% for PSVlow, PSVal, and PSVhigh, respectively (p?<?0.001 level-mode interaction, ANOVA). Right ventricular systolic isovolumetric pressure increased from 11.0?±?4.6 mmHg at PSVlow to 14.0?±?4.6 mmHg at PSVhigh but remained unchanged (11.5?±?4.7 mmHg (NAVAlow) and 10.8?±?4.2 mmHg (NAVAhigh), level-mode interaction p?=?0.005). Both indicate progressive right ventricular outflow impedance with increasing pressure support ventilation (PSV), but no change with increasing NAVA level.Right ventricular performance is less impaired during NAVA compared to PSV as used in this study. Proposed mechanisms are preservation of cyclic intrathoracic pressure changes characteristic of spontaneous breathing and limitation of right-ventricular outflow impedance during inspiration, regardless of the NAVA level.Clinicaltrials.gov Identifier: NCT00647361, registered 19 March 2008.

Project description:BACKGROUND:Protective mechanical ventilation is recommended for patients with acute respiratory distress syndrome (ARDS), but it usually requires controlled ventilation and sedation. Using neurally adjusted ventilatory assist (NAVA) or pressure support ventilation (PSV) could have additional benefits, including the use of lower sedative doses, improved patient-ventilator interaction and shortened duration of mechanical ventilation. We designed a pilot study to assess the feasibility of keeping tidal volume (VT) at protective levels with NAVA and PSV in patients with ARDS. METHODS:We conducted a prospective randomized crossover trial in five ICUs from a university hospital in Brazil and included patients with ARDS transitioning from controlled ventilation to partial ventilatory support. NAVA and PSV were applied in random order, for 15 min each, followed by 3 h in NAVA. Flow, peak airway pressure (Paw) and electrical activity of the diaphragm (EAdi) were captured from the ventilator, and a software (Matlab, Mathworks, USA), automatically detected inspiratory efforts and calculated respiratory rate (RR) and VT. Asynchrony events detection was based on waveform analysis. RESULTS:We randomized 20 patients, but the protocol was interrupted for five (25%) patients for whom we were unable to maintain VT below 6.5 mL/kg in PSV due to strong inspiratory efforts and for one patient for whom we could not detect EAdi signal. For the 14 patients who completed the protocol, VT was 5.8 ± 1.1 mL/kg for NAVA and 5.6 ± 1.0 mL/kg for PSV (p = 0.455) and there were no differences in RR (24 ± 7 for NAVA and 23 ± 7 for PSV, p = 0.661). Paw was greater in NAVA (21 ± 3 cmH2O) than in PSV (19 ± 3 cmH2O, p = 0.001). Most patients were under continuous sedation during the study. NAVA reduced triggering delay compared to PSV (p = 0.020) and the median asynchrony Index was 0.7% (0-2.7) in PSV and 0% (0-2.2) in NAVA (p = 0.6835). CONCLUSIONS:It was feasible to keep VT in protective levels with NAVA and PSV for 75% of the patients. NAVA resulted in similar VT, RR and Paw compared to PSV. Our findings suggest that partial ventilatory assistance with NAVA and PSV is feasible as a protective ventilation strategy in selected ARDS patients under continuous sedation. Trial registration ClinicalTrials.gov (NCT01519258). Registered 26 January 2012, https://clinicaltrials.gov/ct2/show/NCT01519258.

Project description:BACKGROUND:Effective synchronisation of infant respiratory effort with mechanical ventilation may allow adequate gas exchange to occur at lower peak airway pressures, potentially reducing barotrauma and volutrauma and development of air leaks and bronchopulmonary dysplasia. During neurally adjusted ventilatory assist ventilation (NAVA), respiratory support is initiated upon detection of an electrical signal from the diaphragm muscle, and pressure is provided in proportion to and synchronous with electrical activity of the diaphragm (EADi). Compared to other modes of triggered ventilation, this may provide advantages in improving synchrony. OBJECTIVES:Primary• To determine whether NAVA, when used as a primary or rescue mode of ventilation, results in reduced rates of bronchopulmonary dysplasia (BPD) or death among term and preterm newborn infants compared to other forms of triggered ventilation• To assess the safety of NAVA by determining whether it leads to greater risk of intraventricular haemorrhage (IVH), periventricular leukomalacia, or air leaks when compared to other forms of triggered ventilation Secondary• To determine whether benefits of NAVA differ by gestational age (term or preterm)• To determine whether outcomes of cross-over trials performed during the first two weeks of life include peak pressure requirements, episodes of hypocarbia or hypercarbia, oxygenation index, and the work of breathing SEARCH METHODS: We performed searches of the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cohrane Library; MEDLINE via Ovid SP (January 1966 to March 2017); Embase via Ovid SP (January 1980 to March 2017); the Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO host (1982 to March 2017); and the Web of Science (1985 to 2017). We searched abstracts from annual meetings of the Pediatric Academic Societies (PAS) (2000 to 2016); meetings of the European Society of Pediatric Research (published in Pediatric Research); and meetings of the Perinatal Society of Australia and New Zealand (PSANZ) (2005 to 2016). We also searched clinical trials databases to March 2017. SELECTION CRITERIA:We included randomised and quasi-randomised clinical trials including cross-over trials comparing NAVA with other modes of triggered ventilation (assist control ventilation (ACV),synchronous intermittent mandatory ventilation plus pressure support (SIMV ± PS), pressure support ventilation (PSV), or proportional assist ventilation (PAV)) used in neonates. DATA COLLECTION AND ANALYSIS:Primary outcomes of interest from randomised controlled trials were all-cause mortality, bronchopulmonary dysplasia (BPD; defined as oxygen requirement at 28 days), and a combined outcome of all-cause mortality or BPD. Secondary outcomes were duration of mechanical ventilation, incidence of air leak, incidence of IVH or periventricular leukomalacia, and survival with an oxygen requirement at 36 weeks' postmenstrual age.Outcomes of interest from cross-over trials were maximum fraction of inspired oxygen, mean peak inspiratory pressure, episodes of hypocarbia, and episodes of hypercarbia measured across the time period of each arm of the cross-over. We planned to assess work of breathing; oxygenation index, and thoraco-abdominal asynchrony at the end of the time period of each arm of the cross-over study. MAIN RESULTS:We included one randomised controlled study comparing NAVA versus patient-triggered time-cycled pressure-limited ventilation. This study found no significant difference in duration of mechanical ventilation, nor in rates of BPD, pneumothorax, or IVH. AUTHORS' CONCLUSIONS:Risks and benefits of NAVA compared to other forms of ventilation for neonates are uncertain. Well-designed trials are required to evaluate this new form of triggered ventilation.

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Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

Publications

Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

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