Background
Methods
Patients
Study design
Measurements
Cardiac performance
Pulmonary outcomes
Ventilatory modes
Statistical analysis
Sample size
Statistical analysis
Results
Patient characteristics
ID | Age yrs | Sex | BMI kg/m2
| PaCO2
day, kPa | PaO2 day, kPa | HCO3, day, mmol/L | PaCO2
night, kPa | Δ PtCO2 night, kPa | LTOT l/min | FEV1 %pred | FEV1/FVC, % |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | 57 | M | 34.7 | 5.8 | 8.8 | 27.0 | 7.6 | 2.5 | - | 23 | 34 |
2 | 74 | F | 28.0 | 6.3 | 9.3 | 28.6 | 7.0 | 2.8 | 2.0 | 39 | 52 |
3 | 53 | M | 21.4 | 6.1 | 7.7 | 28.3 | 6.5 | 1.3 | - | 28 | 38 |
4 | 70 | F | 27.2 | 6.4 | 8.4 | 27.2 | 6.8 | 5.3 | 4.0 | 35 | 68 |
5 | 67 | M | 35.9 | 7.1 | 9.3 | 36.0 | 7.3 | 2.2 | - | 50 | 66 |
6 | 82 | M | 21.5 | 8.6 | 5.9 | 31.9 | 10.6 | 0.8 | 2.0 | 30 | 63 |
7
|
78
|
F
|
31.6
|
7.6
|
7.8
|
30.6
| 9.6 | 1.5 |
2.5
|
29
|
51
|
8 | 74 | F | 22.5 | 7.8 | 10.9 | 30.6 | 8.0 | 2.5 | 3.0 | 36 | 61 |
9 | 68 | M | 19.4 | 7.3 | 8.8 | 28.6 | 6.9 | 2.7 | 4.0 | 36 | 40 |
10 | 63 | F | 22.8 | 7.4 | 8.6 | 29.3 | 8.2 | 1.3 | 3.0 | 18 | 39 |
11 | 71 | F | 25.1 | 5.9 | 9.6 | 27.0 | 7.4 | 2.6 | 1.0 | 35 | 66 |
12
|
63
|
F
|
27.8
|
8.1
|
8.7
|
28.4
| 8.8 | 4.6 |
3.0
|
37
|
61
|
13
|
60
|
F
|
18.3
|
9.4
|
7.1
|
38.5
| 8.8 | 1.9 |
3.0
|
11
|
38
|
14 | 77 | F | 18.7 | 6.4 | 10.2 | 28.0 | 7.5 | 1.0 | 2.0 | 41 | 49 |
Mean | 68.7 | 25.2 | 6.8 | 8.9 | 29.3 | 7.0 | 2.3 | 34 | 53 | ||
SD | 8.5 | 5.8 | 0.9 | 1.3 | 2.7 | 2.5 | 1.2 | 9 | 13 |
Ventilatory settings
Ventilatory setting | LI-NIV | HI-NIV |
---|---|---|
IPAP, cm H2O, mean ± SD | 15.5 ± 1.1 | 23.6 ± 3.1 |
EPAP, cm H2O, mean ± SD | 5.2 ± 0.6 | 5.4 ± 0.9 |
BURR, breaths/min, mean ± SD | 11.6 ± 1.5 | 15.4 ± 0.8 |
Supplemental oxygen, L/min, mean ± SD | 1.6 ± 1.3 | 1.4 ± 1.2 |
Days needed to initiate NIV, median (range) | 2.7 (2–5) | 4.9 (2–10) |
Number of hours used/day, median (range) | 4.2 (0.04–7.5) | 4.6 (0.11 to 9.2) |
Percentage of days that NIV was used, % (range) | 63 (2–100) | 79 (2–100) |
Mask, nasal, n (%))/oronasal, n (%)) | 3 (27)/8(73) | |
Exhalation, vented mask (n (%))/active valve (n (%)) | 9 (82)/2 (18) | |
Humidification, n (%) | 10 (90) |
Drop-outs
Patient ID | SV (ml) | CO (l/min) | CI (l/min/m2) | LV diastolic | sPAP (mmHg) | RVb (cm) | FAC (%) | TAPSE (mm) | S` (cm/s) |
---|---|---|---|---|---|---|---|---|---|
1
| |||||||||
Baseline | 53 | 5.3 | 2.3 | normal (E/A 0.8) | 33 | 4.2 | 59 | 14 | 10 |
LI-NIVSB, (NIV) | 63 (57) | 5.1 (5.7) | 2.2 (2.1) | na | 4.3 | 55 | 18 | 10 | |
HI-NIV SB (NIV) | 87 (74) | 7.0 (5.6) | 3.1 (2.4) | na | 4.0 | 47 | 17 | 15 | |
2
| |||||||||
Baseline | 56 | 4.6 | 2.7 | normal (E/A 0.9) | na | 3.6 | 44 | 16 | 11 |
LI-NIV SB (NIV) | 72 | 5.5 (5.9) | 3.2 (3.4) | na | 3.7 | 50 | 11 | 12 | |
HI-NIV SB (NIV) | 65 | 4.8 (6.3) | 2.8 (3.6) | na | 4.2 | 45 | 15 | 17 | |
3
| |||||||||
Baseline
|
54
|
4.9
|
2.8
| normal (E/A 1.2) |
na
|
3.9
|
57
|
16
|
15
|
HI-NIV SB (NIV)
|
64 (56)
|
5.9 (6.2)
|
3.3 (3.5)
|
na
|
3.5
|
60
|
21
|
10
| |
LI-NIV SB (NIV)
|
63 (72)
|
5.3 (6.3)
|
3.0 (3.6)
|
na
|
3.0
|
50
|
17
|
11
| |
4
| |||||||||
Baseline | 72 | 6.9 | 3.8 | normal (E/A 1.1) | na | 2.5 | 70 | 16 | 17 |
LI-NIV SB (NIV) | 66 (68) | 5.8 (5.3) | 3.3 (3.1) | na | 3.2 | 66 | 19 | 10 | |
HI-NIV SB (NIV) | 73 (75) | 7.5 (7.7) | 4.3 (4.4) | na | na | na | 19 | 12 | |
5
| |||||||||
Baseline | 53 | 4.4 | 1.8 | restrictive,MV E Vmax 120 cm/s | na | 5.4 | 41 | 20 | na |
HI-NIV SB (NIV) | 77 (89) | 4.9 (5.6) | 2.0 (2.3) | 29 | 3.7 | 20 | 15 | 10 | |
LI-NIV SB (NIV) | 104 (75) | 7.8 (6.5) | 3.2 (2.7) | 18 | 4.2 | na | 18 | na | |
6
| |||||||||
Baseline | 60 | 5.0 | 2.9 | normal (E/A 0.7) | 43 | 4.2 | 50 | 20 | 10 |
HI-NIV SB (NIV) | 56 (na) | 4.0 (na) | 2.3 (na) | 23 | 4.2 | 53 | 23 | 14 | |
LI-NIV SB (NIV) | 92 (na) | 6.0 (na) | 3.4 (na) | 44 | 4.1 | 45 | 22 | 11 | |
7
| |||||||||
Baseline
|
43
|
4.3
|
2.4
| MV E Vmax 80 cm/s |
46
|
4.2
|
11
|
8
| |
LI-NIV SB (NIV)
|
50 (57)
|
3.4 (4.1)
|
1.9 (2.3)
|
37
|
3.8
|
11
|
na
| ||
HI-NIV SB (NIV)
|
45 (50)
|
3.9 (4.5)
|
2.2 (2.5)
|
31
|
4.5
|
13
|
10
| ||
8
| |||||||||
Baseline | 67 | 5.7 | 3,9 | normal (E/A 0.8) | 33 | 2.7 | 45 | 17 | 12 |
LI-NIV SB (NIV) | 66 (68) | 5.2 (5.2) | 3.5 (3.5) | 36 | 2.9 | 50 | 17 | 18 | |
HI-NIV SB (NIV) | 56 (52) | 4.6 (4.2) | 3.2 (2.9) | 36 | 2.9 | 44 | 21 | 10 | |
9
| |||||||||
Baseline | 90 | 7.6 | 4,8 | normal (E/A 0.9) | na | na | na | na | na |
LI-NIV SB (NIV) | 85 (74) | 6.9 (5.3) | 4.4 (3.4) | 26 | 4.2 | 41 | 18 | 16 | |
HI-NIV SB (NIV) | 76 (67) | 6.2 (5.5) | 3.9 (3.5) | 30 | 3.7 | 59 | 19 | 14 | |
10
| |||||||||
Baseline
|
79
|
6.3
|
3.8
| normal (E/A 0.9) |
na
|
3.4
|
70
|
15
|
16
|
HI-NIV SB (NIV)
|
84 (69)
|
4.9 (4.1)
|
2.8 (2.3)
|
na
|
3.9
|
na
|
21
|
10
| |
LI-NIV SB (NIV)
|
86 (83)
|
5.4 (5.3)
|
3.1 (3.0)
|
23
|
3.6
|
48
|
16
|
10
| |
11
| |||||||||
Baseline
|
78
|
4.9
|
2.9
| normal (E/A 0.7) |
34
|
3.2
|
60
|
15
|
15
|
HI-NIV SB (NIV)
|
52 (57)
|
3.0 (3.4)
|
1.8 (2.0)
|
na
|
3.8
|
40
|
23
|
12
| |
LI-NIV SB (NIV)
|
59 (58)
|
4.8 (4.0)
|
2.9 (2.4)
|
25
|
3.7
|
65
|
25
|
12
| |
12
| |||||||||
Baseline
|
86
|
6.8
|
3.8
| normal (E/A 0.9) |
24
|
4.4
|
20
|
12
| |
HI-NIV SB (NIV)
|
81 (68)
|
6.9 (6.4)
|
3.8 (3.6)
|
21
|
4.1
|
25
|
18
| ||
13
| |||||||||
Baseline
|
56
|
4.8
|
3.3
| normal (E/A 1.4) |
39
|
2.5
|
13
|
16
| |
HI-NIV SB (NIV)
|
47 (35)
|
4.1 (3.1)
|
2.9 (2.2)
|
43
|
3.1
|
21
|
11
| ||
14
| |||||||||
Baseline | 68 | 4.8 | 3.4 | normal (E/A 0.7) | na | 3.1 | 47 | 18 | 16 |
LI-NIV SB (NIV) | 61 (60) | 3.5 (3.4) | 2.5 (2.4) | 29 | 3.0 | 50 | 18 | 12 | |
HI-NIV SB (NIV) | 70 (71) | 5.3 (4.7) | 3.7 (3.3) | 28 | 2.8 | 52 | 14 | 14 |
Feasibility of cardiac output measurements in our patients
Echocardiographic abnormalities at baseline
Cardiac performance (completers)
Variable | Order | Baseline | LI-NIV | HI-NIV | Treatment effect HI vs. LI Mean (95% CI) |
P
|
---|---|---|---|---|---|---|
Change in CO, % of baseline | LIHI | −7.8 ± 14.9 | 3.2 ± 19.2 | −8.5% (−27 to 10%) | 0.33 | |
HILI | 17.7 ± 34.6 | −10.3 ± 24.8 | ||||
CO, L/min | LIHI | 5.8 ± 1.1 | 5.3 ± 1.1 | 5.9 ± 1.2 | −0.38 (−1.31 to 0.56) | 0.39 |
HILI | 5.1 ± 0.7 | 5.9 ± 1.1 | 4.5 ± 1.1 | |||
NTproBNP,pg/ml##
| LIHI | 177 (117–317) | 113 (63–197) | 158 (67–208) | 37 (−26 to 101) | 0.22 |
HILI | 215 (61–469) | 199 (91–430) | 158 (88–620) | |||
PaCO2, day, kPa | LIHI | 6.7 ± 0.7 | 6.3 ± 0.7 | 6.1 ± 0.8*
| −2.8 (−6.6 to 1.0) | 0.13 |
HILI | 7.0 ± 1.1 | 6.6 ± 0.7 | 6.0 ± 0.7*
| |||
FEV1, L | LIHI | 0.72 ± 0.14 | 0.79 ± 0.20*
| 0.75 ± 0.21*
| −0.00 (−0.11 to 0.10) | 0.93 |
HILI | 0.95 ± 0.55 | 1.10 ± 0.63*
| 1.13 ± 0.63*
| |||
SRI-SS | LIHI | 43.3 ± 20.2 | 52.2 ± 19.7*
| 49.8 ± 20.8*
| −2.9 (−8.0 to 2.0) | 0.22 |
HILI | 45.2 ± 13.6 | 55.7 ± 8.4*
| 52.6 ± 9.9*
|