Figures
- Fig. 1.—
Trial profile. NPPV: noninvasive positive-pressure ventilation and long-term oxygen therapy; LTOT: long-term oxygen therapy alone.
- 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.—
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.—
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
- Table 1
Evaluations during the study period
Time related to discharge M−1 M0 M1 M3 M6 M9 M12 M15 M18 M21 M24 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
Characteristics NPPV group LTOT group Subjects n 39 47 Sex M:F 32:7 37:10 Age yrs 64±7 66±14 BMI 26±5 25±6 Cigarette smoking pack-yrs 29±6 26±5 FEV1 % pred. 27±8 31±11 VC % pred. 55±17 62±15 RV % pred. 193±78 178±48 TLC % pred. 118±29 110±16 6MWD m 200±125 247±110 MIP cmH2O 50±20 46±21 pH 7.39±0.04 7.39±0.03 Pa,CO2 kPa# 7.2±0.6 7.4±0.6 Pa,O2 kPa# 6.7±0.8 6.6±0.8 Hospital stays day·patient−1·yr−1¶ 19±20 18±18 SGRQ total score 66±14 62±21 LTOT months 30±22 29±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 M0 M12 M24 FEV1 % pred NPPV group 26.6±8.7 26.8±8.9 27.5±10.6 LTOT group 31.0±11.4 30.9±11.3 30.8±11.1 Treatment effect (lower and upper 95% CI) −0.3 (−13.1–+2.4) −1.1 (−4.5–+2.1) VC % pred NPPV group 54.4±17.2 52.9±17.0 55.3±18.2 LTOT group 62.1±14.7 60.0±14.3 59.8±12.3 Treatment effect (lower and upper 95% CI) −0.7 (−6.2–+4.8) −3.1 (−8.1–+1.8) MIP cmH2O NPPV group 50.0±20.0 50.7±19.7 50.6±20.6 LTOT group 45.7±20.9 48.4±27.5 48.1±27.2 Treatment effect (lower and upper 95% CI) 2.1 (−3.6–+7.7) 1.8 (−4.2–+7.9) 6MWD m NPPV group 201±125 202±120 183±118 LTOT group 247±110 244±108 232±111 Treatment effect (lower and upper 95% CI) −4.4 (−37.5–+28.6) 3.3 (−39.0–+45.7) Sleep score NPPV group 2.5±1.1 2.0±0.9 1.7±0.8 LTOT group 2.2±1.2 2.58±1.1 2.3±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
-
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.
