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

E. Clini, C. Sturani, A. Rossi, S. Viaggi, A. Corrado, C.F. Donner, N. Ambrosino
European Respiratory Journal 2002 20: 529-538; DOI: 10.1183/09031936.02.02162001
E. Clini
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C. Sturani
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A. Rossi
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S. Viaggi
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A. Corrado
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C.F. Donner
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N. Ambrosino
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  • Fig. 1.—
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    Fig. 1.—

    Trial profile. NPPV: noninvasive positive-pressure ventilation and long-term oxygen therapy; LTOT: long-term oxygen therapy alone.

  • Fig. 2.—
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    Fig. 2.—

    Time course of oxygen tension in arterial blood (Pa,O2) on a) ambient air and on b) usual oxygen, and of carbon dioxide tension in arterial blood (Pa,CO2) on c) ambient air and on d) usual oxygen over the study period in the study groups. ♦: long-term oxygen therapy (LTOT) alone; •: noninvasive positive-pressure ventilation and LTOT. M: month; M0: discharge. #: p=0.005, treatment effect 2.997, 95% confidence interval (CI) 0.94–5.05; ¶: p=0.002, treatment effect 4.270, 95% CI 1.58–9.96.

  • Fig. 3.—
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    Fig. 3.—

    Time course of Medical Research Council dyspnoea score over the study period in the study groups. ♦: long-term oxygen therapy (LTOT); •: noninvasive positive-pressure ventilation and LTOT. #: p=0.048, treatment effect 0.400, 95% confidence interval (CI) 0.02–0.78; ¶: p=0.013, treatment effect 0.600, 95% CI 0.15–1.05.

  • Fig. 4.—
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    Fig. 4.—

    Change from baseline in total and dimension scores of St George's Respiratory Questionnaire (SGRQ) (a and b) (♦: symptoms; ▪: activity; ▴: impact; •: total) and Maugeri Foundation Respiratory Failure Questionnaire (MRF-28) (c and d) (○: cognitive behaviour; ♦: activity; ▪: disability; ▴: others; •: total). M0: discharge; M24: 24 months after discharge. Group comparison for changes from baseline in total SGRQ score was not significant, p=0.554. #: p=0.041, treatment effect 7.100, 95% confidence interval 0.13–4.07.

Tables

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  • Table 1

    Evaluations during the study period

    Time related to discharge
    M−1M0M1M3M6M9M12M15M18M21M24
    Physical examination✓✓✓✓✓✓✓✓✓✓✓
    Dyspnoea score✓✓✓✓✓✓
    ABG✓✓✓✓✓✓✓✓✓✓✓
    Spirometry✓✓✓✓✓✓
    MIP✓✓✓✓✓✓
    Biochemistry✓✓✓✓
    Chest radiography✓✓✓✓
    ECG✓✓✓
    6MWD✓✓✓
    Sleep quality score✓✓✓✓✓✓
    Polysomnography✓
    MRF-28✓✓✓
    SGRQ✓✓✓
    CT scan#✓
    Echocardiography#✓✓✓
    Drugs check✓✓✓✓✓✓✓✓✓✓✓
    Side-effects✓✓✓✓✓✓✓✓✓
    Hospitalisation✓✓✓✓✓✓✓✓✓
    Treatment compliance✓✓✓✓✓✓✓✓✓
    • M: months

    • M0: discharge

    • ABG: arterial blood gas analysis

    • MIP: maximal inspiratory pressure

    • ECG: electrocardiogram

    • 6MWD: 6-min walking distance test

    • MRF-28: Maugeri Foundation Respiratory Failure Questionnaire

    • SGRQ: St George's Respiratory Questionnaire

    • CT: computed tomography

    • #: optional

  • Table 2

    Demographic, anthropometric, lung function and clinical characteristics of patients at randomisation

    CharacteristicsNPPV groupLTOT group
    Subjects n3947
    Sex M:F32:737:10
    Age yrs64±766±14
    BMI26±525±6
    Cigarette smoking pack-yrs29±626±5
    FEV1 % pred.27±831±11
    VC % pred.55±1762±15
    RV % pred.193±78178±48
    TLC % pred.118±29110±16
    6MWD m200±125247±110
    MIP cmH2O50±2046±21
    pH7.39±0.047.39±0.03
    Pa,CO2 kPa#7.2±0.67.4±0.6
    Pa,O2 kPa#6.7±0.86.6±0.8
    Hospital stays day·patient−1·yr−1¶19±2018±18
    SGRQ total score66±1462±21
    LTOT months30±2229±23
    • Data are presented as mean±sd

    • NPPV: noninvasive positive-pressure ventilation and long-term oxygen therapy

    • LTOT: long-term oxygen therapy

    • M: male

    • F: female

    • BMI: body mass index

    • FEV1: forced expiratory volume in one second

    • VC: vital capacity

    • RV: residual volume

    • TLC: total lung capacity

    • 6MWD: 6-min walking distance test

    • MIP: maximal inspiratory pressure

    • Pa,CO2: carbon dioxide tension in arterial blood

    • Pa,O2: oxygen tension in arterial blood

    • SGRQ: St George's Respiratory Questionnaire

    • #: breathing room air

    • ¶: year mean data for the 3 yrs before the study

  • Table 3

    Time course of lung volumes, respiratory muscle strength, exercise capacity and sleep quality for both groups

    Time related to discharge
    M0M12M24
    FEV1 % pred
     NPPV group26.6±8.726.8±8.927.5±10.6
     LTOT group31.0±11.430.9±11.330.8±11.1
     Treatment effect (lower and upper 95% CI)−0.3 (−13.1–+2.4)−1.1 (−4.5–+2.1)
    VC % pred
     NPPV group54.4±17.252.9±17.055.3±18.2
     LTOT group62.1±14.760.0±14.359.8±12.3
     Treatment effect (lower and upper 95% CI)−0.7 (−6.2–+4.8)−3.1 (−8.1–+1.8)
    MIP cmH2O
     NPPV group50.0±20.050.7±19.750.6±20.6
     LTOT group45.7±20.948.4±27.548.1±27.2
     Treatment effect (lower and upper 95% CI)2.1 (−3.6–+7.7)1.8 (−4.2–+7.9)
    6MWD m
     NPPV group201±125202±120183±118
     LTOT group247±110244±108232±111
     Treatment effect (lower and upper 95% CI)−4.4 (−37.5–+28.6)3.3 (−39.0–+45.7)
    Sleep score
     NPPV group2.5±1.12.0±0.91.7±0.8
     LTOT group2.2±1.22.58±1.12.3±1.3
     Treatment effect (lower and upper 95% CI)0.29 (0.0–+0.7)0.31 (+0.1–+1.0)
    • Data are presented as mean±sd

    • M: month

    • M0: discharge

    • FEV1: forced expiratory volume in one second

    • NPPV: noninvasive positive pressure ventilation and long-term oxygen therapy

    • LTOT: long-term oxygen therapy alone

    • CI: confidence interval

    • VC: vital capacity

    • MIP: maximal inspiratory pressure

    • 6MWD: 6-min walking distance test

    • Patient numbers for analysis of considered variables in NPPV and LTOT groups, respectively: FEV1 39 and 46; VC 39 and 45; MIP 38 and 46; 6MWD 37 and 42; and sleep score 39 and 46

Additional Files

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  • Correction

    Correction, published in Eur Respir J 2002; 20: 1617.

    Files in this Data Supplement:

    • Correction - Correction, published in Eur Respir J 2002; 20: 1617.
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The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients
E. Clini, C. Sturani, A. Rossi, S. Viaggi, A. Corrado, C.F. Donner, N. Ambrosino
European Respiratory Journal Sep 2002, 20 (3) 529-538; DOI: 10.1183/09031936.02.02162001

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The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients
E. Clini, C. Sturani, A. Rossi, S. Viaggi, A. Corrado, C.F. Donner, N. Ambrosino
European Respiratory Journal Sep 2002, 20 (3) 529-538; DOI: 10.1183/09031936.02.02162001
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