NIV Intervention group

Control group

Mortality

NIV therapy reduces the risk of deathby 76% in chronic COPD patients overone-year
1ResMed.com

Study DesignTherapyInvestigator initiated, prospective, multicentre(Germany, Austria), randomised controlled trial of
195 patients (open label but assessors were blinded).

NIV was targeted to reduce baseline PaCO2 by 20% or more,or achieve PaCO2 values lower than 6.5kPa (48.1mm Hg).

Settings and adherence•	Mean IPAP = 21.6 cmH2O (SD 4.7)
• Mean EPAP = 4.8 cmH2O (SD 1.6)• Mean back-up (where used) = 16/min (SD 3.6)
• Mean usage 5.9 hrs (SD 3.1)

Main exclusion criteria•	abnormalities of the thorax or lung other than COPD
•	obesity with a BMI ≥35kg/m2•	severe heart failure

352 patients assessed for eligibility
352 patients assessed for eligibility
157 excluded
did not meet inclusion criteria
157131
excludedparticipate
13126
diddeclined
not meettoinclusion
criteria
26 declined to participate
195 randomised
195 randomised

93 assigned to receive standard COPD
93 assigned
to receiveCOPD
treatment
andstandard
LTOT if indicatedtreatment and LTOT (controlif indicatedgroup)(control group)
93 received allocated intervention
93 received allocated intervention
3 started NPPV during an exacerbation
3 started NPPV during
exacerbation
and anremainedon NPPVand remained on NPPV
93 included in primary analysis
93 included in primary analysis

7.55
2.5
0-2.5-5-7.5-10
Baseline

14 Days

Control group

3 Months

6 Months

Intervention group

9 Months 12 Months
95%-Confidence Interval

Relevance to clinicalpractice

Mortality Risk Reduction of76% over 1 year

Stable, chronic, hypercapnic COPD patients cansignificantly benefit from NIV treatment in terms of
reduced mortality and improved QoL.

One-year mortality in the NIV group was 11.8% vs. 33.3%
in the control group (HR 0.24%, CI 0.11-0.49; p=0.0004).

•	by using an adequate dose (pressure and usage) ofventilation

0·40•	and focusing on reducing PaCO2 as the clinical target.

0·30

Control group
Intervention groupp = 0·0004

n = 1020·100Control group (n=93)

Age, years

64.4 (80)62.2 (8.6)

Number at risk

Male, n (%)

56 (60%)65 (6.4%)

Body-mass index, kg/m2

24.5 (5.8)

24.8 (5.8)

Control group
Intervention group

FVC % predicted

53.3% (13.8)

50.4% (13.3)

FEV1 predicted

27.5% (8.9)

26% (11.0)

41.2% (11.4)

40.4% (11.5)

102 assigned to receive standard COPD
102treatment
assigned toreceive
COPD
andLTOT standard
if indicated,
andtreatment
and LTOT if indicated,
NPPV (interventiongroup) andNPPV (intervention group)

Residual volume/total lung capacity, %72.7% (8.9)

73.0% (8.5)

pH

7.39 (0.05)

7.39 (0.04)

PaC02, kPa

7.7 (0.7)

7.8 (0.8)

Pa02, kPa*

8.7 (1.9)

8.6 (2.1)

102 received allocated intervention
102 received allocated intervention

Sa02, %*

90.8% (5.9)

90.3% (6.2)

HCO3, mmol/L

33.9 (4.1)

34.3 (40)

2 lost to follow-up
2 lostto follow-up intervention
9 discontinued
9 discontinued intervention

Base excess, mmol/L

8.0 (309)

7.8 (3.8)

6-min walk distance, m

249.6 (145.3)

226.7 (121.2)

Long term oxygen treatment, n (%)

60 (65%)67 (66%)102 included in primary analysis
102 included in primary analysis
Data are mean (SD), unless otherwise stated. FVC=forced vital capacity. FEV1=forced expiratory volume in 1s.
PaCO2=arterial carbon dioxide pressure. PaO2=arterial oxygen pressure. SaO2=arterial oxygen saturation.
HCO3=bicarbonate. *In patients with long term oxygen was applied via nasal cannula
at the previously prescribed flow rate.

n = 930·20

Non-invasive
positive pressure
ventilation group (n=102)

FEV2/FVC %Figure 1: Trial profile
Figure 1: Trial profile
COPD=chronic obstructive pulmonary disease. LTOT=long-term oxygen therapy.
COPD=chronic obstructive pulmonary disease. LTOT=long-term oxygen therapy.
NPPV=non-invasive positive pressure ventilation.
NPPV=non-invasive positive pressure ventilation.

10

Outcome assessors were blinded to treatment.

-	a control group (n=93) that received optimised standardtreatment.

The primary outcome was one-year all-cause mortality andanalysis was intention to treat.

Using the St George’s Respiratory Questionnaire,patients treated with NIV reported that their quality oflife was 5.8 points higher than patients treated without
NIV (p=0.0289).

Support ventilation mode (plus back-up rate preferred) andadvised to use > 6hrs/day.

Patients were randomised to;-	a treatment group (n=102) who received NIV for at least
12 months.

PaCO2 (p<0.0001)

Cumulative mortality

 table GOLD stage IV COPD and a partial pressure ofS
carbon dioxide (PaCO2) of 7 kPa (51.9 mmHg) or higher
and pH higher than 7.35 (non acidotic) measured after at
least one hour rest in a sitting position.

Better quality of life

Percent change to baseline

Non-invasive positive pressure ventilation for the treatment ofsevere, stable chronic obstructive pulmonary disease:1a prospective, multicentre, randomised, controlled clinical trial.

0100

200300400Time (days after randomisation)

931027795“NIV improves survival, and quality of life,2

if CO2 is reduced”

Mark Elliott, Department of Respiratory Medicine,
St James University Hospital, Leeds, UK.

72
92

6990

1 PD Dr. Thomas Köhnlein, et al. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease a prospective, multicentre, randomised, controlled clinical trial.
The Lancet Respiratory Medicine 2014 Jul 24. pii: S. 2213 – 2600(14)70153-5. doi: 10.1016 / S. 2213 – 2600(14)70153-5. (Epub ahead of print) (NIPPV zur Behandlung schwerer stabiler COPD – eine prospektive,
multizentrische, randomisierte, kontrollierte klinische Studie).
2 Domiciliary NIV for COPD: where are we now? Elliott, M. The Lancet Respiratory Medicine 25th July 2014.

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