Volume-Targeted Versus Pressure-Limited Noninvasive Ventilation in Subjects With Acute Hypercapnic Respiratory Failure: A Multicenter Randomized Controlled Trial

Respir Care. 2016 Nov;61(11):1440-1450. doi: 10.4187/respcare.04619. Epub 2016 Oct 18.

Abstract

Background: 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.).

Keywords: acute hypercapnic respiratory failure; hypercapnia; noninvasive ventilation; pressure-limited; target tidal volume; volume-targeted.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Aged
  • Aged, 80 and over
  • China
  • Female
  • Hospital Mortality
  • Humans
  • Hypercapnia / mortality
  • Hypercapnia / therapy*
  • Male
  • Middle Aged
  • Noninvasive Ventilation / methods*
  • Noninvasive Ventilation / mortality
  • Positive-Pressure Respiration*
  • Prospective Studies
  • Respiratory Insufficiency / mortality
  • Respiratory Insufficiency / therapy*
  • Tidal Volume
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02538263