Figures
- FIGURE 1
At-home noninvasive ventilation (NIV) initiation protocol. Five steps that comprise at-home NIV initiation with a nonexhaustive description of the actions performed by the different actors.
- FIGURE 2
Flowchart of patients included between September 2017 and June 2021. ALS: amyotrophic lateral sclerosis; NIV: noninvasive ventilation.
Tables
- TABLE 1
Population characteristics
Patient characteristics at initiation Total At-home patients Inpatients p-value Anthropometric data Patients, n 265 184 81 Age (years) 68±11 68±11 69±9 0.577 Male 157 (63) 114 (62) 43 (65) 0.645 BMI (kg·m−2) 24±4 24±4 23±4 0.141 Smoking greater than 20 pack-years 23 (9) 16 (9) 7 (11) 0.684 Neurological assessment ALSFRS-R score 33±7 33±7 33±7 0.854 Time from symptoms onset to NIV initiation (months) 29±25 29±24 27±26 0.521 Time from diagnosis to NIV initiation (months) 15±18 17±20 10±13 0.016 Bulbar symptoms at NIV initiation 131 (53) 94 (51) 37 (56) 0.513 Gastrostomy in the follow-up 13 (5) 9 (5) 4 (6) 0.714 Frontotemporal dementia 19 (8) 15 (8) 4 (6) 0.582 Respiratory assessment FVC (L) 2.32±0.89 2.40±0.84 2.07±0.10 0.042 FVC (%) 68.9±20.9 71.60±19.97 59.4±21.7 <0.001 Peak flow (L·s−1) 4.59±2.02 4.75±1.98 4.01±2.10 0.066 Peak flow (%) 63.4±24.8 65.65±24.65 54.8±23.7 0.017 MIP (cmH2O) 44.4±23.9 44.26±23.96 45.1±24 0.877 SNIP (cmH20) 45.9±20.8 47.88±23.89 43.2±17.5 0.692 SpO2 night-time <90% (%) 17±21.4 15.16±18.59 23.2±28.1 0.023 SpO2<90% more than 5% of night-time 142 (68) 114 (62) 28 (58) 0.118 SpO2 minimum 80.4±7.85 80.7±7.77 79.4±8.12 0.345 SpO2 mean 91.9±2.36 92.1±1.98 91.3±3.29 0.070 ODI 9.63±10.1 9.25±8.92 10.9±13.4 0.357 PaCO2 (kPa) 5.39±1.04 5.07±0.58 6.21±1.44 <0.001 NIV initiation criteria Clinical signs + PaCO2>6.1 kPa 34 (13) 0 34 (42) FVC <80% only 84 (32) 65 (35) 19 (24) 0.056 SpO2<90%, time >5% only 74 (28) 72 (39) 2 (2) <0.001 Both FVC <80% and SpO2<90%, time >5% 42 (16) 42 (23) 0 (0) <0.001 SNIP <60 cmH2O 1 (0) 1 (1) 0 (0) 0.506 Other 30 (11) 4 (2) 26 (32) <0.001 Time from NIV requirement assessment to initiation (days) 12.5±16.5 8.72±6.47 29±31.1 <0.001 Data are presented as mean±sd or n (%) unless otherwise stated. ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised; BMI: body mass index; FVC: forced vital capacity; MIP: maximal inspiratory pressure; ODI: oxygen desaturation index; NIV: noninvasive ventilation; PaCO2: arterial carbon dioxide tension; SNIP: sniff nasal inspiratory pressure; SpO2: oxygen saturation measured by pulse oximetry.
- TABLE 2
Population characteristics at noninvasive ventilation (NIV) initiation depending on adherence assessment at day 30
Patient characteristics at initiation Total Adherence >4 h Adherence <4 h p-value Anthropometric data Patients 233 153 (66) 80 (34) Age (years) 68±11 68.1±10.6 68±11.2 0.907 Male 148 (63) 101 (66) 47 (59) 0.274 BMI (kg·m−2) 24±5 24.4±4.64 23±4.13 0.028 Smoking greater than 20 pack-years 21 (9) 12 (7.8) 9 (11) 0.381 Initiation modality At home 181 (78) 126 (82) 55 (69) 0.018 In hospital 52 (22) 27 (18) 25 (31) 0.018 Time from NIV requirement assessment to initiation (days) 12.3±16.6 12.6±19.1 11.5±10.2 0.647 Died before the 30th day 12 (5) 0 (0) 12 (15) Neurological assessment ALSFRS-R score 32.9±7.28 34.3±6.36 30.5±8.21 0.003 Time from symptoms onset to NIV initiation (months) 28.2±24.1 28.9±24.7 26.6±22.9 0.519 Time from diagnosis to NIV initiation (months) 14.9±18.6 15.3±18.2 14±19.5 0.623 Bulbar symptoms at NIV initiation 122 (52.6) 75 (49) 47 (59) 0.173 Gastrostomy in the follow-up 13 (5.6) 8 (5) 5 (6) 0.747 Frontotemporal dementia 18 (7.7) 11 (7) 7 (9) 0.672 Respiratory assessment FVC (L) 2.33±0.871 2.4±0.842 2.17±0.921 0.108 FVC (%) 68.7±20.9 71.5±21.5 62.9±18.2 0.007 Peak flow (L·s−1) 4.58±1.99 4.8±2.04 4.08±1.81 0.036 Peak flow (%) 63.2±24.7 65.6±25.3 57.6±22.5 0.053 MIP (cmH2O) 44.7±23.7 46.6±22.8 40.2±25.6 0.178 SNIP (cmH20) 45.4±22.4 56±24.4 34.8±15.7 0.104 SpO2 night-time <90% (%) 17.1±21.3 17.8±20.6 15.8±22.6 0.531 SpO2<90% more than 5% of night-time 135 (68.2) 95 (62) 40 (50) 0.024 SpO2 minimum 80.4±7.88 80.8±8.33 79.6±7.01 0.317 SpO2 mean 91.9±10.3 91.8±2.43 92.1±2.37 0.468 ODI 9.91±10.3 9.49±11.9 10.6±11.9 0.477 PaCO2 (kPa) 5.36±1 5.39±1.04 5.29±0.9 0.489 Data are presented as mean±sd or n (%) unless otherwise stated. ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale–Revised; BMI: body mass index; FVC: forced vital capacity; MIP: maximal inspiratory pressure; ODI: oxygen desaturation index; PaCO2: arterial carbon dioxide tension; SNIP: sniff nasal inspiratory pressure; SpO2: oxygen saturation measured by pulse oximetry.
- TABLE 3
Noninvasive ventilation (NIV) parameters and monitoring at day 30 for the whole cohort
Total At-home patients Inpatients p-value NIV parameters Patients, n 221 179 42 IPAP (cmH20) 12.2±2.31 11.8±1.98 14±2.81 <0.001 EPAP (cmH20) 6.7±1.49 6.66±1.48 6.85±1.53 0.465 Back-up respiratory rate (acts per minute) 13.5±1.25 13.4±1.17 14.2±1.36 <0.001 Rise time (ms) 428±138 439±134 372±149 0.007 Trigger (L·min−1) 5.89±0.88 5.97±0.62 5.53±1.62 0.007 Cycling (%IPF) 23.4±5.67 23.1±5.24 25±7.66 0.082 tI min (s) 0.664±0.640 0.644±0.570 0.769±0.922 0.293 tI max (s) 1.78±0.305 1.80±0.289 1.70±0.371 0.078 NIV monitoring Days (n) 31.4±10.1 30.6±7.07 35.3±18.2 0.009 Days without use (n) 4.26±8.66 3.88±7.01 5.95±13.8 0.172 Patients with fractional use (n) 23 (10) 10 (6) 13 (31) <0.001 NIV use (h) 6.15±3.23 5.99±2.87 6.85±4.48 0.126 VT (mL) 439±118 427±89.7 490±193 0.002 Respiratory rate (acts per minute) 16.8±3.13 16.5±2.73 18±4.32 0.007 Leaks (L·min−1) 5.57±15.1 3.69±10.7 13.7±25.6 <0.001 Leaks >24 L·min−1 (n) 10 (5) 4 (2) 6 (14) <0.001 AHI 6.52±9.36 5.48±8.77 11.1±10.6 <0.001 AHI >10 (n) 41 (19) 27 (15) 14 (33) 0.004 12 deaths before day 30 were excluded from analysis. Data are presented as mean±sd or n (%) unless otherwise stated. AHI: apnoea–hypopnoea index; EPAP: expiratory positive airway pressure; IPAP: inspiratory positive airway pressure; IPF: inspiratory peak flow; VT: tidal volume; tI: inspiratory time.
- TABLE 4
Noninvasive ventilation (NIV) parameters and monitoring at day 30 for adherent patients of the at-home NIV initiation subgroup
Day 30 Corrected SpO2 Noncorrected SpO2 p-value NIV parameters Patients, n 126 99 (79) 21 (17) IPAP (cmH20) 12.1±1.97 12±1.9 12.8±2.29 0.118 EPAP (cmH20) 6.86±1.52 6.75±1.47 7.75±1.37 0.006 Back-up respiratory rate (acts per minute) 13.4±1.17 13.5±1.15 13.3±1.03 0.531 Rise time (ms) 444±134 447±140 439±115 0.602 Trigger (L·min−1) 5.96±0.57 5.95±0.64 6±0 0.736 Cycling (%IPF) 23±5.39 22.7±5.47 24±5.53 0.345 tI min (s) 0.674±0.67 0.698±0.7 0.6±0.16 0.566 tI max (s) 1.8±0.3 1.80±0.3 1.81±0.31 0.862 Face mask 121 (96) 96 (97) 18 (90) 0.156 NIV monitoring Days (n) 29.5±3.07 29.6±3.18 28.6±2.58 0.169 Days without use 1.57±1.57 1.55±3.45 0.286±0.72 0.099 Patients with fractional use 3 (2) 2 (2) 1 (5) 0.444 NIV use (h) 7.58±1.50 7.45±1.48 8.17±1.36 0.043 VT (mL) 426±88 420±80.9 456±113 0.099 Respiratory rate (acts per minute) 16.2±5.55 16.3±2.62 15.4±1.79 0.131 Leaks (L·min−1) 4.04±12.2 3.98±13.2 4.74±8.66 0.805 Leaks >24 L·min−1 4 (3) 3 (3) 1 (5) 0.656 AHI 6.33±9.71 5.63±8.38 10.1±14.9 0.066 AHI >10 24 (19) 16 (16) 6 (30) 0.146 SpO2 assessment SpO2 night-time <90 (%) 3.62±7.01 1.38±1.56 14.2±11.8 <0.001 There were six missing results. Data are presented as mean±sd or n (%) unless otherwise stated. AHI: apnoea-hypopnoea index; EPAP: expiratory positive airway pressure; IPAP: inspiratory positive airway pressure; IPF: inspiratory peak flow; SpO2: oxygen saturation measured by pulse oximetry; tI: inspiratory time; VT: tidal volume.
Supplementary Material
Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.
Progress of the at-home NIV initiation protocol 00438-2022.supplement1
NIV parameters at initiation 00438-2022.supplement2
NIV parameters and monitoring at day 30 for the whole cohort 00438-2022.supplement3
Patients' characteristics at initiation in subgroup ADH >4 h 00438-2022.supplement4
