Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial
Abstract
:1. Introduction
Objectives
2. Materials and Methods
2.1. Trial Design and Participants
2.2. Measures
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- Arterial blood gas analysis (ABG) (pH, PaCO2, PaO2, HCO3) measured 4 h after awakening;
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- Pulmonary function testing, including spirometry, performed following the European Respiratory Society guidelines [24], with the patient in a seated and supine position via a flanged mouthpiece, and using the suggested reference values [25], forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and FEV1/FVC% (Master Screen Body Jaeger Vyntus™ Pneumo, Vyaire, Mettawa, IL, USA);
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- Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) (MicroRPM Pressure Meter, Micro Medical Ltd., Lewiston, ME, USA) via a flanged mouthpiece while the cheeks were held. Three measurements for a total of eight performed with less than 5% variability were recorded, and the highest value was used for the data analysis (patients with MEP < 60 cmH2O were provided with a Cough Assist device) [26,27];
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- Overnight cardiorespiratory polygraphy with a nasal flow sensor, thoracic and abdominal effort measured with inductive plethysmography, and finger pulse oximeter (Embletta™ PDS, Medicare, Iceland), according to the American Academy of Sleep Medicine clinical practice guidelines: apnoea and hypopnea were scored manually using standard criteria [28,29];
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- 36-item Short Form Survey (SF-36) [30], a questionnaire on the patient’s health status;
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- At T1 (after the 8-day adaptation period), the following evaluations were performed:
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- ABG measured 4 h after awakening;
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- Verification of NIV acceptance, i.e., mean use of ≥5 h NIV per night for 3 consecutive nights during the adaptation trial;
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- A visual analog scale (VAS), on which the patient indicated the degree of satisfaction with NIV management and nursing assistance (0–10, low–high);
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- Educational learning test designed to verify the knowledge and skills acquired by the patient concerning the path taken by the physiotherapist (see Supplementary Material Table S1).
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- ABG measured 4 h after awakening;
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- Overnight cardiorespiratory polygraphy with airway pressure proximal to the mask thoracic and abdominal effort measured with inductive plethysmography and finger pulse oximeter;
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- Verification of adherence to NIV (night-time NIV usage for ≥150 h/month);
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- Optimization of the ventilator parameters [34];
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- VAS, SF-36, CBI, CBS, and ZBI (as above).
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- ABG measured 4 h after awakening;
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- Overnight cardiorespiratory polygraphy;
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- Verification of adherence to NIV;
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- BDS and ESS;
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- VAS, SF-36, CBI, CBS, and ZBI.
2.3. Intervention: The NIV Adaptation Trial
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- Home Adaptation (HA): in addition to the usual medical care, patients received no fewer than 8 sessions in the afternoon for about two hours at home with assistance provided by the Respiratory Therapist (RT) to help them adapt to NIV and education on the management of bronchial secretions.
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- Outpatient Adaptation (OA): in addition to the usual medical treatment, patients attended no fewer than 8 sessions in the afternoon for about two hours in the outpatient clinic to help them adapt to NIV and were educated about the management of bronchial secretions.
2.3.1. Criteria for a Correct Adaptation to NIV
2.3.2. Criteria for Acceptance of NIV
2.3.3. Sample Size
2.3.4. Randomization, Sequence Generation, and Allocation Concealment
2.4. Statistical Analysis
3. Results
4. Discussion
Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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Characteristics | Overall Sample (n = 66) | Home Adaptation (HA) (n = 34) | Outpatient Adaptation (OA) (n = 32) | p-Value |
---|---|---|---|---|
Female, n, % | 36 (54.5) | 14 (41.2) | 16 (50) | |
Age, y, mean (SD) | 69.1 (8.6) | 67.4 (7.5) | 70.9 (9.5) | 0.11 |
BMI, mean (SD) | 24.09 (6.7) | 23.4 (2.9) | 24.7 (4.3) | 0.15 |
Bulbar onset, n, % | 19 (28.8) | 7 (20.6) | 12 (37.5) | |
Spinal onset, n, % | 43 (65.1) | 25 (73.5) | 18 (56.2) | |
Respiratory onset, n, % | 4 (6.1) | 2 (5.9) | 2 (6.3) | |
ALS duration (from symptom onset), months, mean (SD) | 32 (4.7) | 31.6 (5.2) | 32.3 (4) | 0.53 |
FVC (% predicted) | 69.9 (23.8) | 70 (23.09) | 70 (21.4) | 0.52 |
FEV1 (% predicted) | 68 (24.3) | 72 (22.8) | 64 (25.8) | 0.20 |
FEV1/FVC (% predicted) | 99.3 (2.4) | 98.8 (1.8) | 99.7 (2.2) | 0.40 |
MIP (% predicted) | 40.2 (17.4) | 44.7 (16.05) | 35.2 (17.7) | 0.26 |
MEP (% predicted) | 47.2 (26.4) | 37.9 (20.8) | 43.3 (27.5) | 0.25 |
Ventilatory Mode, n, % | ||||
S/T AVAPS | 30 (45.5) | 13 (38.2) | 17 (53.1) | |
S/T | 28 (42.2) | 19 (55.8) | 9 (26.5) | |
PACV | 7 (10.6) | 2 (5.9) | 5 (14.7) | |
APC/AVAPS | 1 (1.5) | 0 (0) | 1 (2.9) | |
Kind of masks used, n, % | ||||
Respironics non-vented masks | 66 (100) | 34 (100) | 32 (100) | |
Comfort Gel Blue Full | 25 (37.9) | 14 (41.2) | 11 (34.4) | |
Easy Life | 18 (27.3) | 9 (26.5) | 9 (28.1) | |
Amara Gel | 23 (34.8) | 11 (32.3) | 12 (35.3) | |
ECAS, mean (SD) | 90.5 (6.82) | 90.5 (3.8) | 90 (9.03) | 0.55 |
ALSFRS-R, mean (SD) | 29.2 (6.6) | 28.7 (6.4) | 29.8 (6.9) | 0.53 |
ALSFRS-R Bulbar score, mean (SD) | 9.84 (1.04) | 9.71 (1.11) | 9.91 (0.99) | 0.50 |
BORG Dyspnoea Scale, mean (SD) | 0.49 (0.5) | 0.39 (0.8) | 0.59 (0.31) | 0.19 |
ESS, mean (SD) | 9.2 (0.4) | 9.8 (0.3) | 9.4 (0.4) | 0.25 |
Outcomes | Baseline | After Adaptation | Follow Up (2 Months Later) | Follow Up (6 Months Later) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
HA n = 34 | OA n = 32 | 95%Cl, p Value | HA n = 34 | OA n = 32 | 95%Cl, p Value | HA n = 31 | OA n = 27 | 95%Cl, p Value | HA n = 31 | OA n = 27 | 95%Cl, p-Value | |
ABG | ||||||||||||
ph, mean (SD) | 7.39 (1.27) | 7.42 (0.44) | 7.32–7.42, p = 0.34 | 7.39 (2.8) | 7.39 (3.1) | p = 0.34 | 7.39 (3.45) | 7.41 (0.02) | 7.35–7.37, p = 0.33 | 7.42 (0.02) | 7.40 (14.6) | 7.37–7.39, p = 0.33 |
PaCO2, mean (SD) | 42.29 (5.56) | 43.58 (8.17) | 41.21–44.62, p = 0.46 | 34.6 (3.3) | 34.9 (2.9) | p = 0.46 | 33.0 (17.24) | 29.93 (19.16) | 27.05–35.97, p = 0.50 | 43.4 (2.81) | 43.3 (2.29) | 38.0–48.0, p = 0.46 |
PaO2, mean (SD) | 77 (9.13) | 75.26 (9.84) | 73.83–78.88, p = 0.46 | 78.1 (9) | 77.4 (9.7) | p = 0.46 | 77.0 (5.79) | 77.9 (6.71) | 75.67–79.15, p = 0.61 | 78.3 (5.95) | 76.27 (6) | 68.0–91.0, p = 0.24 |
HCO3, mean (SD) | 29.97 (3.95) | 29.19 (3.72) | 28.19–30.96, p = 0.80 | 27.8 (3.4) | 28.1 (3.61) | p = 0.28 | 29.24 (2.16) | 29.74 (1.74) | 28.03–30.91, p = 0.37 | 29.95 (2.02) | 31.04 (1.9) | 24.2–33.0, p = 0.11 |
SaO2, mean (SD) | 94.17 (2.17) | 94.51 (2.8) | 93.72–94.95, p = 0.59 | 95.2 (2.12) | 94.9 (2.1) | p = 0.21 | 94.51 (1.47) | 95.00 (1.38) | 93.33–95.15, p = 0.24 | 94.86 (1.38) | 94.53 (1.49) | 92.0–97.0, p = 0.44 |
Polygraphy | ||||||||||||
AHI, mean (SD) | 13.34 (11.71) | 19.99 (17.96) | 12.58–20.22, p = 0.09 | --- | --- | --- | 5.90 (4.99) | 6.65 (5.83) | 7.47–13.7, p = 0.09 | 5.20 (4.57) | 7.11 (7.45) | 4.58–7.66, p = 0.22 |
SpO2, mean (SD) | 91.91 (2.13) | 90.69 (3.51) | 90.60–92.05, p = 0.10 | --- | --- | --- | 91.8 (5.2) | 92.1 (6.1) | 89.1–93.5, p = 0.88 | 91.60 (16.25) | 91.43 (16.76) | 87.46–95.47, p = 0.96 |
ODI, mean (SD) | 11.47 (10.36) | 11.10 (7.52) | 8.95–13.36, p = 0.76 | --- | --- | --- | 8.6 (3.8) | 8.15 (3.23) | 1.72–2.44, p = 0.05 | 4.85 (4.91) | 6.57 (8.20) | 4.00–7.36, p = 0.31 |
T90%, mean (SD) | 14.78 (26.03) | 27.38 (34.78) | 13.00–28.04 p = 0.10 | --- | --- | --- | 7.61 (6.62) | 5.7 (6.63) | 2.34–2.54, p = 0.07 | 12.09 (6.07) | 12.08 (2.06) | 1.98–11.88, p = 0.14 |
Baseline | Follow Up (2 Months Later) | Follow Up (6 Months Later) | |||||||
---|---|---|---|---|---|---|---|---|---|
Outcomes | Home Adaptation (HA) n = 34 | Outpatient Clinic Adaptation (OA) n = 32 | 95% Cl, p-Value | Home Adaptation (HA) n = 29 | Outpatient Clinic Adaptation (OA) n = 23 | 95% Cl, p-Value | Home Adaptation (HA) n = 29 | Outpatient Clinic Adaptation (OA) n = 23 | 95% Cl, p-Value |
SF-36, mean (SD) | 26.78 (7.92) | 25.19 (9.71) | 22.36–27.32, p = 0.150 | 52.21 (32.04) | 38.69 (21.63) | 41.43–56.66, p = 0.011 | 28.2 (3.57) | 30.0 (4.80) | 15.0–30.0; p = 0.171 |
Physical Component Summary(PCS) | 6.59 (3.88) | 6.06 (3.92) | 1.4–13.1, p = 0.636 | 62.8 (31.7) | 35.1 (18.6) | 17.1–99, p = 0.551 | 28.2 (3.57) | 30 (4.80) | 0–30.8, p = 0.967 |
Mental Component Summary(MCS) | 7.44 (3.88) | 6.75 (4.10) | 0–13.4, p = 0.588 | 24.1 (16.5) | 21.8 (13.8) | 0–50.1, p = 0.446 | 15.5 (9.73) | 15.6 (8.45) | 0–29.9, p = 0.517 |
Physical Functioning(PF) | 18.5 (5.70) | 19.7 (5.10) | 10–27.3, p = 0.494 | 15.3 (11.2) | 17.5 (11.9) | 0–40, p = 0.742 | 16 (8.68) | 14.6 (9.33) | 10–19.9, p = 0.719 |
Role Physical(RP) | 9.59 (2.33) | 8.44 (2.15) | 6.1–13.2, p = 0.395 | 10.4 (1.07) | 10.5 (1.19) | 9.2–12.3, p = 0.068 | 9.97 (10.5) | 9.47 (5.95) | 0–12, p = 0.409 |
Bodily Pain(BP) | 73.8 (4.20) | 72.90 (4.09) | 67.3–80, p = 0.143 | 13.5 (4.03) | 11.6 (4.45) | 6–20.5, p = 0.066 | 7.84 (3.97) | 7 (4.15) | 0–10.9, p = 0.847 |
General Health(GH) | 27.9 (4.69) | 25.6 (4.38) | 20.2–34, p = 0.419 | 73.9 (4.94) | 71.6 (4.96) | 63.8–80, p = 0.369 | 6.25 (2.69) | 4.19 (3.43) | 5.3–30, p = 0.010 |
Vitality(VT) | 42.7 (5.89) | 42.1 (5.32) | 34–52.5, p = 0.251 | 12 (6.46) | 13.6 (7.58) | 2–25, p = 0.578 | 14.6 (16.8) | 18 (8.67) | 10–16.3, p = 0.078 |
Social Functioning(SF) | 31.7 (3.51) | 31.1 (3.37) | 27.1–37, p = 0.471 | 18.8 (6.44) | 17.9 (6.06) | 8.1–30, p = 0.486 | 7.13 (4.24) | 7.84 (4.40) | 6.7–30, p = 0.508 |
Role Emotional(RE) | 77.7 (9.26) | 77.3 (9.07) | 60.4–90.2; p = 0.871 | 26.3 (12.6) | 22.7 (13.2) | 3.4–45, p = 0.269 | 25.9 (15) | 24.8 (13.8) | 1.2–50, p = 0.776 |
Mental Health(MH) | 62.8 (8.15) | 63.8 (8.75) | 51.3–78, p = 0.814 | 43.1 (24.5) | 41.3 (26.1) | 1–44, p = 0.772 | 6.88 (4.48) | 6.41 (4.60) | 2–14.3, p = 0.681 |
CBI, mean (SD) | 20.51 (16.31) | 23.60 (13.50) | 17.99–25.45, p = 0.652 | 16.35 (17.26) | 13.28 (14.11) | 10.51–21.9, p = 0.486 | 24.22 (13,64) | 24.89 (12.61) | 11.2–25.3; p = 0.008 |
ZBI, mean (SD) | 23.87 (15.86) | 28.72 (16.08) | 21.71–30.86, p = 0.150 | 18.16 (17.98) | 14.00 (16.73) | 11.42–20.60, p = 0.591 | 25.94 (15.81) | 26.89 (14.60) | 10.4–27.1; p = 0.847 |
CBS, mean (SD) | 47.33 (22.43) | 37.89 (23.71) | 36.39–49.45, p = 0.206 | 31.00 (29.21) | 23.78 (23.71) | 10.70–28.77, p = 0.991 | 46.57 (19.93) | 38.31 (17.85) | 36.0–51.0; p = 0.269 |
Home Adaptation (HA) | Outpatient Clinic Adaptation (OA) | |||||
---|---|---|---|---|---|---|
Outcomes | Baseline | Follow-Up (2 Months Later) | 95% Cl, p-Value | Baseline | Follow-Up (2 Months Later) | 95% Cl, p-Value |
SF-36, mean (SD) | 26.78 (7.92) | 52.21 (32.04) | 18.69–42.15, p = 0.000 | 25.19 (9.71) | 38.69 (21.63) | 4.11–22.88, p = 0.007 |
CBI, mean (SD) | 20.51 (16.31) | 16.35 (17.26) | 2.08–10.40, p = 0.183 | 23.60 (13.50) | 13.28 (14.11) | 2.68–17.95, p = 0.010 |
ZBI, mean (SD) | 23.87 (15.86) | 18.16 (17.98) | 0.070–11.42, p = 0.050 | 28.72 (16.08) | 14.00 (16.73) | 4.24–19.06, p = 0.003 |
CBS, mean (SD) | 47.33 (22.43) | 31.00 (29.21) | 4.96–27.70, p = 0.008 | 37.89 (23.71) | 23.78 (23.71) | 0.12–28.33, p = 0.052 |
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Volpato, E.; Vitacca, M.; Ptacinsky, L.; Lax, A.; D’Ascenzo, S.; Bertella, E.; Paneroni, M.; Grilli, S.; Banfi, P. Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial. J. Clin. Med. 2022, 11, 3178. https://0-doi-org.brum.beds.ac.uk/10.3390/jcm11113178
Volpato E, Vitacca M, Ptacinsky L, Lax A, D’Ascenzo S, Bertella E, Paneroni M, Grilli S, Banfi P. Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial. Journal of Clinical Medicine. 2022; 11(11):3178. https://0-doi-org.brum.beds.ac.uk/10.3390/jcm11113178
Chicago/Turabian StyleVolpato, Eleonora, Michele Vitacca, Luciana Ptacinsky, Agata Lax, Salvatore D’Ascenzo, Enrica Bertella, Mara Paneroni, Silvia Grilli, and Paolo Banfi. 2022. "Home-Based Adaptation to Night-Time Non-Invasive Ventilation in Patients with Amyotrophic Lateral Sclerosis: A Randomized Controlled Trial" Journal of Clinical Medicine 11, no. 11: 3178. https://0-doi-org.brum.beds.ac.uk/10.3390/jcm11113178