Two-year home-based nocturnal noninvasive ventilation added to rehabilitation in chronic obstructive pulmonary disease patients: a randomized controlled trial

Abstract

Background: The use of noninvasive intermittent positive pressure ventilation (NIPPV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure remains controversial as long-term data are almost lacking. The aim was to compare the outcome of 2-year home-based nocturnal NIPPV in addition to rehabilitation (NIPPV + PR) with rehabilitation alone (PR) in COPD patients with chronic hypercapnic respiratory failure.

Methods: Sixty-six patients could be analyzed for the two-year home-based follow-up period. Differences in change between the NIPPV + PR and PR group were assessed by a linear mixed effects model with a random effect on the intercept, and adjustment for baseline values. The primary outcome was health-related quality of life (HRQoL); secondary outcomes were mood state, dyspnea, gas exchange, functional status, pulmonary function, and exacerbation frequency.

Results: Although the addition of NIPPV did not significantly improve the Chronic Respiratory Questionnaire compared to rehabilitation alone (mean difference in change between groups -1.3 points (95% CI: -9.7 to 7.4)), the addition of NIPPV did improve HRQoL assessed with the Maugeri Respiratory Failure questionnaire (-13.4% (-22.7 to -4.2; p = 0.005)), mood state (Hospital Anxiety and Depression scale -4.0 points (-7.8 to 0.0; p = 0.05)), dyspnea (Medical Research Council -0.4 points (-0.8 to -0.0; p = 0.05)), daytime arterial blood gases (PaCO2 -0.4 kPa (-0.8 to -0.2; p = 0.01); PaO2 0.8 kPa (0.0 to 1.5; p = 0.03)), 6-minute walking distance (77.3 m (46.4 to 108.0; p < 0.001)), Groningen Activity and Restriction scale (-3.8 points (-7.4 to -0.4; p = 0.03)), and forced expiratory volume in 1 second (115 ml (19 to 211; p = 0.019)). Exacerbation frequency was not changed.

Conclusions: The addition of NIPPV to pulmonary rehabilitation for 2 years in severe COPD patients with chronic hypercapnic respiratory failure improves HRQoL, mood, dyspnea, gas exchange, exercise tolerance and lung function decline. The benefits increase further with time.

Trial registration: ClinicalTrials.Gov (ID NCT00135538).

Figure 1

Flow diagram of the study progress. The present article presents the results of the home-based 3-24 month period, shown with a black square around it. QoL: health-related Quality of Life; ABG: arterial blood gases; 6MWD: 6-minute walking distance; LF: lung function measurements.

Figure 2

Maugeri Respiratory Failure scores. MRF scores at the different measurement points in the NIPPV + rehabilitation group (black triangles) and the rehabilitation group (grey blocks). Lower scores signify better quality of life. The change was significantly better in the NIPPV + rehabilitation group (p < 0.02).

Figure 3

Daytime arterial blood gases. Daytime arterial blood gases without additional oxygen at the different measurement points in the NIPPV + rehabilitation group (black triangles) and the rehabilitation group (grey blocks). The change was significantly better in the NIPPV + rehabilitation group (p < 0.02).

Figure 4

6-minute walking distance. 6MWD in meters at the different measurement points in the NIPPV + rehabilitation group (black triangles) and the rehabilitation group (grey blocks). The change was significantly better in the NIPPV + rehabilitation group (p < 0.001).

Figure 5

Forced expiratory volume in 1 second (FEV₁). FEV₁ in liters (L) at the different measurement points in the NIPPV + rehabilitation group (black triangles) and the rehabilitation group (grey blocks). The change was significantly better in the NIPPV + rehabilitation group (p < 0.02).