The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients

Abstract

Chronic obstructive pulmonary disease (COPD) patients with chronic ventilatory failure (CVF) are more likely to develop exacerbations, which are an important determinant of health-related quality of life (HRQL). Long-term noninvasive positive-pressure ventilation (NPPV) has been proposed in addition to long-term oxygen therapy (LTOT) to treat CVF but little information is available on its effects on HRQL and resource consumption. Therefore, the current authors undertook a 2-yr multicentric, prospective, randomised, controlled trial to assess the effect of NPPVz LTOT on: 1) severity of hypercapnia; 2) use of healthcare resources, and 3) HRQL, in comparison with LTOT alone.One hundred and twenty-two stable hypercapnic COPD patients on LTOT for o6 months were consecutively enrolled. After inclusion and 1-month run-in, 90 patients were randomly assigned to NPPVzLTOT (n=43) or to LTOT alone (n=47). Arterial blood gases, hospital and intensive care unit (ICU) admissions, total hospital and ICU length of stay and HRQL were primary outcome measures; survival and drop-out rates, symptoms (dyspnoea and sleep quality) and exercise tolerance were secondary outcome measures. Follow-up was performed at 3-month intervals up to 2 yrs.Lung function, inspiratory muscle function, exercise tolerance and sleep quality score did not change over time in either group. By contrast the carbon dioxide tension in arterial blood on usual oxygen, resting dyspnoea and HRQL, as assessed by the Maugeri Foundation Respiratory Failure Questionnaire, changed differently over time in the two groups in favour of NPPVzLTOT. Hospital admissions were not different between groups during the follow-up. Nevertheless, overall hospital admissions showed a different trend to change in the NPPVzLTOT (decreasing by 45%) as compared with the LTOT group (increasing by 27%) when comparing the follow-up with the followback periods. ICU stay decreased over time by 75% and 20% in the NPPVzLTOT and LTOT groups, respectively. Survival was similar.Compared with long-term oxygen therapy alone, the addition of noninvasive positivepressure ventilation to long-term oxygen therapy in stable chronic obstructive pulmonary disease patients with chronic ventilatory failure: 1) slightly decreased the trend to carbon dioxide retention in patients receiving oxygen at home and 2) improved dyspnoea and health-related quality of life. The results of this study show some significant benefits with the use of nocturnal, home noninvasive positive-pressure ventilation in patients with chronic ventilatory failure due to advanced chronic obstructive pulmonary disease patients. Further work is required to evaluate the effect of noninvasive positive-pressure ventilation on reducing the frequency and severity of chronic obstructive pulmonary disease exacerbation. Eur Respir J 2002; 20: 529-538.

Nonpharmacological treatment and relief of symptoms in COPD

“…One trial [83] indicated that there was no overall survival benefit from NPPV plus LTOT, despite a slight improvement in survival for patients aged .65 yrs. An Italian 2-yr multicentric trial showed that NPPV plus LTOT improved daytime Pa,CO 2 , dyspnoea and QoL, although survival was similar to that in the control (LTOT alone) group [84]. In this and another observational controlled study [85], ICU admissions were reduced during NPPV compared with the LTOT regimen.…”

“…The benefits of NPPV in stable patients are equivocal, with little evidence to support NPPV in addition to LTOT in the treatment of chronic hypercapnic COPD [82]. Two large multicentric trials have focused on NPPV in this population [83,84]. One trial [83] indicated that there was no overall survival benefit from NPPV plus LTOT, despite a slight improvement in survival for patients aged .65 yrs.…”

Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation

“…31,32 The unblinded trial design and lack of a sham device, with blinded assessment in terms of the outcome, is consistent with other clinical trials in this field. 11,12,14,15 Second, the trial design was pragmatic in that it made provision for patients initially allocated to home oxygen therapy to have home noninvasive ventilation added if they breached safety criteria after reaching the primary outcome. Eighteen patients initially allocated to home oxygen therapy alone had home noninvasive ventilation added to their management strategy.…”

Home ventilation

“…A recent Italian multicentric study showed lower Pa,CO 2 , reduced dyspnoea score and improved quality of life in COPD patients using NIV compared to LTOT [45]. Hospital admissions did not differ between the groups but intensive care unit admissions fell among NIV users.…”