Restricted accessResearch articleFirst published online 2016-11
Volume-Targeted Versus Pressure-Limited Noninvasive Ventilation in Subjects With Acute Hypercapnic Respiratory Failure: A Multicenter Randomized Controlled Trial
Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that delivers a preset target tidal volume (VT) through the automated adjustment of pressure support, could guarantee a relatively constant target VT over pressure-limited noninvasive ventilation (PL-NIV) with fixed-level pressure support. Whether VT-NIV is more effective in improving ventilatory status in subjects with acute hypercapnic respiratory failure (AHRF) remains unclear. Our aim was to verify whether, in comparison with PL-NIV, VT-NIV would be more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in subjects with AHRF.
METHODS:
We performed a prospective randomized controlled trial in the general respiratory wards of 8 university-affiliated hospitals in China over a 12-month period. Subjects with AHRF, defined as arterial pH <7.35 and ≥7.25 and PaCO2 >45 mm Hg, were randomly assigned to undergo PL-NIV or VT-NIV. The primary end point was the decrement of PaCO2 from baseline to 6 h after randomization. Secondary end points included the decrement of PaCO2 from baseline to 2 h after randomization as well as outcomes of subjects (eg, need for intubation, in-hospital mortality).
RESULTS:
A total of 58 subjects were assigned to PL-NIV (29 subjects) or VT-NIV (29 subjects) and included in the analyses. The decrement of PaCO2 from baseline to 6 h after randomization was not statistically different between the PL-NIV group and the VT-NIV group (9.3 ± 12.6 mm Hg vs 11.7 ± 12.9 mm Hg, P = .48). There were no differences between the PL-NIV group and the VT-NIV group in the decrement of PaCO2 from baseline to 2 h after randomization (6.4 ± 12.7 mm Hg vs 5.0 ± 15.8 mm Hg, P = .71) as well as in the need for intubation (17.2% vs 10.3%, P = .70), and in-hospital mortality (10.3% vs 6.9%, P > .99).
CONCLUSIONS:
Regardless of whether a VT- or PL-NIV strategy is employed, it is possible to provide similar support to subjects with AHRF. (ClinicalTrials.gov registration NCT02538263.)
ChandraD, StammJA, TaylorB, RamosRM, SatterwhiteL, KrishnanJA, et al. Outcomes of noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease in the United States, 1998-2008. Am J Respir Crit Care Med, 2012; 185(2):152–159.
2.
CabriniL, EsquinasA, PasinL, NardelliP, FratiE, PintaudiM, et al. An international survey on noninvasive ventilation use for acute respiratory failure in general non-monitored wards. Respir Care, 2015; 60(4):586–592.
3.
StefanMS, ShiehMS, PekowPS, RothbergMB, SteingrubJS, LaguT, LindenauerPK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med, 2013; 8(2):76–82.
4.
WalkeyAJ, WienerRS. Use of noninvasive ventilation in patients with acute respiratory failure, 2000-2009: a population-based study. Ann Am Thorac Soc, 2013; 10(1):10–17.
5.
EstebanA, Frutos-VivarF, MurielA, FergusonND, PeñuelasO, AbrairaV, et al. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med, 2013; 188(2):220–230.
6.
PlantPK, OwenJL, ElliottMW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet, 2000; 355(9219):1931–1935.
7.
BrochardL, ManceboJ, WysockiM, LofasoF, ContiG, RaussA, et al. Noninvasive ventilation for acute exacerbations of chronic obstructive pulmonary disease. N Engl J Med, 1995; 333(13):817–822.
8.
KramerN, MeyerTJ, MehargJ, CeceRD, HillNS. Randomized, prospective trial of noninvasive positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care Med, 1995; 151(6):1799–1806.
9.
CelikelT, SungurM, CeyhanB, KarakurtS. Comparison of noninvasive positive pressure ventilation with standard medical therapy in hypercapnic acute respiratory failure. Chest, 1998; 114(6):1636–1642.
10.
Collaborative Research Group of Noninvasive Mechanical Ventilation for Chronic Obstructive Pulmonary Disease. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: a multicentre randomized controlled trial. Chin Med J, 2005; 118(24):2034–2040.
11.
LightowlerJV, WedzichaJA, ElliottMW, RamFS. Non-invasive positive pressure ventilation to treat respiratory failure resulting from exacerbations of chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis. BMJ, 2003; 326(7382):185.
12.
RamFS, PicotJ, LightowlerJ, WedzichaJA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev, 2004(3):CD004104.
13.
PeterJV, MoranJL, Phillips-HughesJ, GrahamP, BerstenAD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet, 2006; 367(9517):1155–1163.
14.
WengCL, ZhaoYT, LiuQH, FuCJ, SunF, MaYL, et al. Meta-analysis: noninvasive ventilation in acute cardiogenic pulmonary edema. Ann Intern Med, 2010; 152(9):590–600.
15.
ParkM, SangeanMC, Volpe MdeS, FeltrimMI, NozawaE, LeitePF, et al. Randomized, prospective trial of oxygen, continuous positive airway pressure, and bilevel positive airway pressure by face mask in acute cardiogenic pulmonary edema. Crit Care Med, 2004; 32(12):2407–2415.
16.
MasipJ, BetbeséAJ, PáezJ, VecillaF, CañizaresR, PadróJ, et al. Non-invasive pressure support ventilation versus conventional oxygen therapy in acute cardiogenic pulmonary oedema: a randomised trial. Lancet, 2000; 356(9248):2126–2132.
17.
AntonelliM, ContiG, BufiM, CostaMG, LappaA, RoccoM, et al. Noninvasive ventilation for treatment of acute respiratory failure in patients undergoing solid organ transplantation: a randomized trial. JAMA, 2000; 283(2):235–241.
18.
HilbertG, GrusonD, VargasF, ValentinoR, Gbikpi-BenissanG, DuponM, et al. Noninvasive ventilation in immunosuppressed patients with pulmonary infiltrates, fever, and acute respiratory failure. N Engl J Med, 2001; 344(7):481–487.
19.
NavaS, AmbrosinoN, CliniE, PratoM, OrlandoG, VitaccaM, et al. Noninvasive mechanical ventilation in the weaning of patients with respiratory failure due to chronic obstructive pulmonary disease. A randomized, controlled trial. Ann Intern Med, 1998; 128(9):721–728.
20.
FerrerM, EsquinasA, ArancibiaF, BauerTT, GonzalezG, CarrilloA, et al. Noninvasive ventilation during persistent weaning failure: a randomized controlled trial. Am J Respir Crit Care Med, 2003; 168(1):70–76.
21.
Collaborating Research Group for Noninvasive Mechanical Ventilation of Chinese Respiratory Society. Pulmonary infection control window in treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi-centred study. Chin Med J, 2005; 118(19):1589–1594.
22.
HessDR. The evidence for noninvasive positive-pressure ventilation in the care of patients in acute respiratory failure: a systematic review of the literature. Respir Care, 2004; 49(7):810–829.
23.
Lloyd-OwenSJ, DonaldsonGC, AmbrosinoN, EscarabillJ, FarreR, FaurouxB, et al. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survey. Eur Respir J, 2005; 25(6):1025–1031.
24.
VrijsenB, ChatwinM, ContalO, DeromE, JanssensJP, KampelmacherMJ, et al. Hot topics in noninvasive ventilation: report of a working group at the International Symposium on Sleep-Disordered Breathing in Leuven, Belgium. Respir Care, 2015; 60(9):1337–1362.
25.
TuggeyJM, ElliottMW. Randomised crossover study of pressure and volume non-invasive ventilation in chest wall deformity. Thorax, 2005; 60(10):859–864.
26.
JanssensJP, MetzgerM, SforzaE. Impact of volume targeting on efficacy of bi-level non-invasive ventilation and sleep in obesity-hypoventilation. Respir Med, 2009; 103(2):165–172.
27.
StorreJH, SeutheB, FiechterR, MilioglouS, DreherM, SorichterS, WindischW. Average volume-assured pressure support in obesity hypoventilation: a randomized crossover trial. Chest, 2006; 130(3):815–821.
28.
MurphyPB, DavidsonC, HindMD, SimondsA, WilliamsAJ, HopkinsonNS, et al. Volume targeted versus pressure support non-invasive ventilation in patients with super obesity and chronic respiratory failure: a randomised controlled trial. Thorax, 2012; 67(8):727–734.
29.
AmbrogioC, LowmanX, KuoM, MaloJ, PrasadAR, ParthasarathyS. Sleep and non-invasive ventilation in patients with chronic respiratory insufficiency. Intensive Care Med, 2009; 35(2):306–313.
30.
CrisafulliE, ManniG, KidoniasM, TrianniL, CliniEM. Subjective sleep quality during average volume assured pressure support (AVAPS) ventilation in patients with hypercapnic COPD: a physiological pilot study. Lung, 2009; 187(5):299–305.
31.
StorreJH, MatrosovichE, EkkernkampE, WalkerDJ, SchmoorC, DreherM, WindischW. Home mechanical ventilation for COPD: high-intensity versus target volume noninvasive ventilation. Respir Care, 2014; 59(9):1389–1397.
32.
Briones ClaudettKH, Briones ClaudettM, Chung Sang WongM, Nuques MartinezA, Soto EspinozaR, MontalvoM, et al. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med, 2013; 13:12.
33.
FerrerM, ValenciaM, NicolasJM, BernadichO, BadiaJR, TorresA. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med, 2006; 173(2):164–170.
34.
PatrickW, WebsterK, LudwigL, RobertsD, WiebeP, YounesM. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med, 1996; 153(3):1005–1011.
35.
MehtaS, JayGD, WoolardRH, HiponaRA, ConnollyEM, CiminiDM, et al. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Crit Care Med, 1997; 25(4):620–628.
36.
DiazO, IglesiaR, FerrerM, ZavalaE, SantosC, WagnerPD, et al. Effects of noninvasive ventilation on pulmonary gas exchange and hemodynamics during acute hypercapnic exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med, 1997; 156(6):1840–1845.
