| Helmet noninvasive ventilation (N = 31) | High-flow nasal oxygen (N = 33) | Absolute or mean difference (95% CI) | Odds ratio (95% CI) | P value |
---|---|---|---|---|---|
Symptoms | |||||
 Anyone of the following symptoms—N (%) | 28 (90) | 28 (85) | 5 (− 11 to 22) | 1.67 (0.36 to 7.65) | 0.71 |
 Fatigue—N (%) | 17 (55) | 18 (55) | 0 (− 0.23 to 0.23) | 1.01 (0.38 to 2.71) |  > 0.99 |
 Dyspnea—N (%) | 22 (71) | 21 (64) | 7 (− 15 to 29) | 1.4 (0.49 to 4.00) | 0.60 |
 mMRC scale (range 0–4) | 2 [1–2] | 2 [2–3] | 0.17 (− 0.16 to 0.51) |  | 0.25 |
 Dry cough—N (%) | 2 (6) | 3 (9) | − 03 (− 18 to 13) | 0.69 (0.11 to 4.43) |  > 0.99 |
 Sore throat—N (%) | 0 (0) | 2 (6) | − 6 (− 20 to 6) | - | 0.49 |
 Productive cough—N (%) | 0 (0) | 0 (0) | 0 (− 0 to 11) | - | - |
 Rhinitis—N (%) | 2 (6) | 1 (3) | 3 (− 10 to 18) | 2.21 (0.19 to 25.64) | 0.61 |
 Smell disorder—N (%) | 3 (10) | 1 (3) | 7 (− 7 to 22) | 3.43 (0.34 to 34.86) | 0.35 |
 Decreased visual acuity– N (%) | 5 (16) | 2 (6) | 10 (− 6 to 27) | 2.98 (0.53 to 16.66) | 0.25 |
 Conjunctival hyperaemia—N (%) | 0 (0) | 0 (0) | 0 (− 0 to 11) | - | - |
 Taste disorder—N (%) | 2 (6) | 2 (6) | 0 (14 to 15) | 1.07 (0.14 to 8.09) |  > 0.99 |
 Inappetence—N (%) | 1 (3) | 2 (6) | − 3 (− 17 to 11) | 0.52 (0.04 to 6.00) |  > 0.99 |
 Diarrhoea—N (%) | 4 (13) | 0 (0) | 13 (0 to 29) | - | 0.05 |
 Myalgia—N (%) | 9 (29) | 12 (36) | − 7 (− 29 to 15) | 0.72 (0.25 to 2.05) | 0.60 |
 Arthralgia—N (%) | 5 (16) | 18 (55) | − 38 (− 56 to − 15) | 0.16 (0.05 to 0.52) | 0.002 |
 Chest pain—N (%) | 3 (10) | 2 (6) | 4 (− 11 to 9) | 1.66 (0.26 to 10.68) | 0.67 |
 Sicca syndrome—N (%) | 1 (3) | 1 (3) | 0 (− 12 to 13) | 1.07 (0.06 to 17.83) | > 0.99 |
 Raynaud syndrome—N (%) | 0 (0) | 0 (0) | 0 (− 10 to 11) | - | - |
 Skin lesion—N (%) | 0 (0) | 0 (0) | 0 (− 10 to 11) | - | - |
 Syncope—N (%) | 0 (0) | 0 (0) | 0 (− 10 to 11) | - | - |
 Dizziness—N (%) | 1 (3) | 0 (0) | 3 (− 8 to 16) | - | 0.48 |
 Headache—N (%) | 0 (0) | 0 (0) | 0 (− 10 to 11) | - | - |
Physical performance test | |||||
---|---|---|---|---|---|
Pulmonary performance test | Helmet noninvasive ventilation (N = 30) | High-flow nasal oxygen (N = 30) | Absolute or mean difference (95% CI) | Odds ratio (95% CI) | P value |
Forced vital capacity % of predicted | 92 [84–104] | 88 [80–98] | − 6.03 (− 13.96 to 1.88) |  | 0.22 |
Forced vital capacity < 80% of predicted—N (%) | 4 (13) | 7 (22) | − 9 (− 27 to 11) | 0.55 (0.14 to 2.11) | 0.51 |
Forced expiratory volume in one second % of predicted | 94 [87–108] | 93 [80–102] | − 4.95 (− 12.8 to 2.90) |  | 0.31 |
Forced expiratory volume in one second < 80% of predicted—N (%) | 3 (10) | 7 (23) | − 13 (− 31 to 7) | 0.38 (0.09 to 1.64) | 0.30 |
Forced expiratory volume in one second/Forced vital capacity ratio | 0.81 [0.77–0.85] | 0.82 [0.79–0.85] | 0.02 (− 0.01 to 0.05) |  | 0.47 |
Forced expiratory volume in one second/Forced vital capacity ratio < 80% of predicted—N (%) | 7 (23) | 11 (37) | − 14 (− 35 to 9) | 1.99 (0.65 to 6.10) | 0.27 |
Maximal (mid-) expiratory flow 25–75—litres per second | 1.13 [0.97–1.33] | 1.16 [0.95–1.37] | 0.02 (− 0.15 to 0.19) |  | 0.95 |
Total lung capacity % of predicted | 90 [85–98] | 88 [77–92] | − 6.22 (− 13.22 to 0.88) |  | 0.12 |
Total lung capacity < 80% of predicted—N (%) | 4 (13) | 10 (33) | − 20 (− 40 to 2) | 0.31 (0.08 to 1.13) | 0.13 |
Diffusing capacity of the lung for carbon monoxide % of predicted | 78 [70–85] | 76 [67–88] | − 1.41 (− 10.43 to 7.60) |  | 0.67 |
Diffusing capacity of the lung for carbon monoxide < 80% of predicted—N (%) | 15 (52) | 19 (63) | − 0.12 (− 0.34 to 0.13) | 0.62 (0.22 to 1.76) | 0.44 |
Alveolar ventilation—litres | 5.41 [4.32–5.99] | 5.45 [4.29–5.86] | 0.11 (− 0.50 to 0.72) |  | 0.95 |
Diffusing capacity of the lung for carbon monoxide/alveolar ventilation ratio | 0.94 [0.84–1.02] | 0.96 [0.86–1.04] | 0.02 (− 0.08 to 0.11) |  | 0.64 |
Residual volume % of predicted | 84 [75–97] | 84 [69–91] | − 5.33 (− 15.05 to 4.39) |  | 0.41 |
Residual volume < 80% of predicted—N (%) | 11 (37) | 11 (35) | 2 (− 22 to 24) | 1.05 (0.37 to 2.99) |  > 0.99 |
Residual volume/total lung capacity ratio % of predicted | 90 [83–101] | 90 [83–99] | − 0.1 (− 6.42 to 6.22) |  | 0.96 |
Six minutes walking test | Helmet noninvasive ventilation (N = 30) | High-flow nasal oxygen (N = 30) | Absolute or mean difference (95% CI) | Odds ratio (95% CI) | P value |
---|---|---|---|---|---|
Distance walked—metres | 490 [420–540] | 510 [438–540] | − 5.23 (− 56.63 to 46.17) |  | 0.82 |
Percentage of predicted value—% | 127 [115–150] | 125 [105–144] | − 8.61 (− 24.23 to 7.01) |  | 0.36 |
Less than lower limit of the predicted value—N (%) | 1 (4) | 4 (15) | − 10 (− 28 to 7) | 0.20 (0.02 to 1.96) | 0.18 |
SpO2 nadir during test—% | 94 [91–95] | 94 [91–95] | − 0.006 (− 0.02 to 0.01) |  | 0.50 |
Recovery time to return SpO2 to basal value—minutes | 1 [1–2] | 2 [1–2] | 0.36 (− 0.16 to 0.88) |  | 0.43 |
Maximum heart rate—beats per minutes | 107 [99–116] | 103 [99–112] | − 2.17 (− 9.01 to 4.68) |  | 0.46 |
Recovery time to return heart rate to basal value—minutes | 2 [2–3] | 2 [2–3] | 0.23 (− 0.27 to 0.72) |  | 0.36 |
BORG scale for dyspnea during test (range 0–10) | 4 [2–6] | 3 [3–5] | − 0.24 (− 1.43 to 0.95) |  | 0.91 |
Interruption of test—N (%) | 0 (0) | 1 (3) | − 3 (− 17 to 8) | - | 0.49 |
Quality-of-life assessment | Helmet noninvasive ventilation (N = 35) | High-flow nasal oxygen (N = 36) | Absolute or mean difference (95% CI) | Odds ratio (95% CI) | P value |
---|---|---|---|---|---|
EQ-VAS (range 0–100) | 78 [69–80] | 70 [60–80] | − 4.67 (− 11.39 to 2.05) |  | 0.27 |
EQ-5D-5L | |||||
 Impairment in mobility (mobility > 1)—N (%) | 10 (29) | 14 (39) | − 10 (− 31 to 11) | 0.63 (0.23 to 1.70) | 0.45 |
 Impairment in personal care (personal care > 1)—N (%) | 7 (20) | 8 (22) | − 2 (− 21 to 17) | 0.88 (0.28 to 2.74) | > 0.99 |
 Impairment in usual activities (usual activities > 1)—N (%) | 11 (31) | 17 (47) | − 16 (− 36 to 7) | 0.51 (0.20 to 1.35) | 0.23 |
 Reported pain or discomfort (pain or discomfort > 1)—N (%) | 19 (54) | 21 (58) | − 4 (− 26 to 18) | 0.85 (0.33 to 2.17) | 0.81 |
 Reported anxiety or depression (anxiety or depression > 1)—N (%) | 12 (34) | 14 (39) | − 5 (− 26 to 17) | 0.82 (0.31 to 2.16) | 0.81 |
PCL-5 (range 0–100) | 11 [3–17] | 8 [2–17] | 0.07 (− 7.37 to 7.51) |  | 0.71 |
SF-36 | |||||
 Physical functioning (range 0–100) | 85 [39–95] | 78 [34–95] | − 4.11 (− 20.00 to 11.78) |  | 0.53 |
 Limitations due to physical health (range 0–100) | 50 [0–100] | 50 [0–100] | − 3.53 (− 24.61 to 17.54) |  | 0.68 |
 Limitations due to emotional problems (range 0–100) | 67 [25–100] | 100 [33–100] | 7.65 (− 12.79 to 28.08) |  | 0.41 |
 Energy/fatigue (range 0–100) | 60 [40–75] | 60 [36–74] | − 2.75 (− 13.25 to 7.76) |  | 0.56 |
 Emotional well-being (range 0–100) | 76 [60–88] | 78 [61–88] | 1.09 (− 8.50 to 10.68) |  | 0.90 |
 Social functioning (range 0–100) | 88 [63–100] | 75 [41–88] | − 7.80 (− 20.56 to 4.97) |  | 0.16 |
 Pain (range 0–100) | 85 [55–100] | 78 [55–90] | − 4.35 (− 16.50 to 7.79) |  | 0.33 |
 General health (range 0–100) | 60 [45–75] | 55 [35–74] | − 3.12 (− 14.12 to 7.88) |  | 0.52 |
 Health change (range 0–100) | 25 [25–50] | 38 [25–50] | 2.44 (− 10.89 to 15.77) |  | 0.72 |