Chest
Volume 118, Issue 6, December 2000, Pages 1582-1590
Journal home page for Chest

Clinical Investigations
COPD
Long-term Controlled Trial of Nocturnal Nasal Positive Pressure Ventilation in Patients With Severe COPD

https://doi.org/10.1378/chest.118.6.1582Get rights and content

Study objectives:

To determine the 1-year efficacy ofnoninvasive positive pressure ventilation (NPPV) added to long-termoxygen therapy (LTOT) in patients with stable severe COPD.

Patient selection and methods:

We prospectively randomized52 patients with severe COPD (FEV1 < 45%) to either NPPVplus “standard care” (96% patients with LTOT) or to standard carealone (93% patients with LTOT). The outcomes measured included thefollowing: rate of acute COPD exacerbations; hospital admissions; intubations; and mortality at 3 months, 6 months, and 12 months. Thepatients were also evaluated at 3 months and 6 months for dyspnea usingthe Medical Research Council and Borg scales, gas exchange, hematocrit, pulmonary function, cardiac function with echocardiogram, andneuropsychological performance.

Results:

One-yearsurvival was similar in both groups (78%). The number of acuteexacerbations was similar at all time points in patients receiving, NPPV, compared with control subjects. The number of hospital admissionswas decreased at 3 months in the NPPV group (5% vs 15% of patients, p < 0.05), but this difference was not seen at 6 months (18% vs19%, respectively). The only beneficial differences were observed inthe Borg dyspnea rating, which dropped from 6 to 5 (p < 0.039), andin one of the neuropsychological tests (psychomotor coordination) forthe NPPV group at 6 months.

Conclusions:

Our studyindicates that over 1 year, NPPV does not affect the natural course ofthe disease and is of marginal benefit in outpatients with severe COPDwho are in stable condition.

Section snippets

Patient Selection

Eighty patients with severe COPD from the pulmonary clinics oftwo hospitals in the Canary Islands (Hospital Clinico and Hospital Nuestra Señora de La Candelaria, Canary Islands, Spain) wereasked to participate in the study, which was approved by the humansstudy committee at both institutions. All patients signed the informedconsent and were enrolled between 1995 and 1997. The patients wereincluded if they met the following criteria: age from 45 to 75 years, smoking history of > 20 pack-years,

Patient Characteristics

The 52 patients were randomized into one group treated with NPPV(n = 26) and a control group (n = 26). In spite of theencouragement, five patients from the treatment group did not tolerateventilation within the first 3 weeks. All complained about pressuresbeing too high. Another patient stopped participation after asignificant aortic stenosis was diagnosed at a follow-upechocardiography. Two patients from the control group also abandonedthe trial because of abnormal echocardiographic findings

Discussion

To our knowledge, this prospective study is thelargest and longest prospective, randomized, controlled trial of NPPVin patients with stable severe COPD.1011121314313233 Inaddition, it is the only one that analyzes the influence of NPPV on1-year morbidity and mortality. Over this time, we were unable todemonstrate an important benefit of NPPV when added to standardtreatment. There was an improvement in the Borg dyspnea scale and inone neuropsychological test at 6 months, but the clinical

References (41)

  • Lung transplantation: report of the ATS workshop on lung transplantation: American Thoracic Society, Medical Section of the American Lung Association

    Am Rev Respir Dis

    (1993)
  • TJ Meyer et al.

    Noninvasive positive pressure ventilation to treat respiratory failure

    Ann Intern Med

    (1994)
  • N Ambrosino

    Noninvasive mechanical ventilation in acute respiratory failure

    Eur Respir J

    (1996)
  • Clinical indications for noninvasive positive pressure ventilation in chronic respiratory failure due to restrictive lung disease COPD, and nocturnal hypoventilation: a consensus conference report

    Chest

    (1999)
  • JR Catterall et al.

    Mechanism of transient hypoxemia in hypoxic chronic bronchitis and emphysema

    J Appl Physiol

    (1985)
  • RD Ballard et al.

    Influence of sleep on respiratory function in emphysema

    Am J Respir Crit Care Med

    (1995)
  • MW Elliot et al.

    Domiciliary nocturnal nasal intermittent positive pressure ventilation in COPD: mechanisms underlying changes in arterial blood gas tensions

    Eur Respir J

    (1991)
  • DA Strumpf et al.

    Nocturnal positive pressure ventilation via nasal mask in patients with severe chronic obstructive pulmonary disease

    Am Rev Respir Dis

    (1991)
  • MA Morales et al.

    The short-term effects of nocturnal domiciliary mechanical ventilation with nasal continuous positive pressure in patients with chronic obstructive pulmonary disease

    Arch Bronconeumol

    (1993)
  • DJ Meecham Jones et al.

    Nasal pressure ventilation plus oxygen compared with oxygen therapy alone in hypercapnic COPD

    Am J Respir Crit Care Med

    (1995)
  • Cited by (332)

    • Noninvasive bilevel positive airway pressure therapy

      2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second Edition
    View all citing articles on Scopus

    Supported in part by a grant from the Spanish Respiratory Society.

    View full text