Table 1.
Baseline characteristics of patients in the helmet noninvasive ventilation and usual respiratory support groups in the modified intention-to-treat population, which included patients who died by day 180, and the health-related quality of life (HRQoL) population consisting of patients who were alive and responded to the HRQoL questionnaire
| Characteristic | Non-survivors by day 180 | HRQoL population | ||
|---|---|---|---|---|
| Helmet noninvasive ventilation (N = 63) | Usual respiratory support (N = 65) | Helmet noninvasive ventilation (N = 96) | Usual respiratory support (N = 93) | |
| Age (years), median (IQR) | 64 (53, 71) | 64 (55, 72) | 54 (43, 62) | 56 (49, 63) |
| Male sex, N (%) | 44 (69.8) | 34 (52.3) | 58 (60.4) | 49 (52.7) |
| BMI (kg/m2), median (IQR) | 30.1 (26.8, 33.1) | 29.4 (27, 33.2) | 30.3 (26.3, 35.7) | 30.8 (26.6, 34.8) |
| APACHE II score, median (IQR) | 14 (11, 19) | 15 (11, 19) | 12 (9, 14) | 13 (9, 16) |
| SOFA score, median (IQR) | 3 (2, 4) | 3 (2, 4) | 2 (2, 3) | 2 (2, 3) |
| Comorbidities, N (%)a | ||||
| Any chronic comorbidity | 46 (73) | 52 (80) | 62 (64.6) | 63 (67.7) |
| Diabetes | 38 (60.3) | 40 (61.5) | 48 (50) | 54 (58.1) |
| Chronic cardiac disease | 32 (50.8) | 22 (33.8) | 25 (26) | 29 (31.2) |
| Chronic pulmonary disease | 14 (22.2) | 6 (9.2) | 10 (10.4) | 13 (14) |
| Chronic renal disease on dialysis | 6 (9.5) | 6 (9.2) | 2 (2.1) | 2 (2.2) |
| Malignancy | 4 (6.3) | 4 (6.2) | 4 (4.2) | 6 (6.5) |
| Confirmed COVID-19 at the time of enrollment, N (%)b | 61 (96.8) | 65 (100) | 94 (97.9) | 91 (97.8) |
| Respiratory support at enrollment, N (%) | ||||
| High-flow nasal oxygen | 35 (55.6) | 28 (43.1) | 58 (60.4) | 48 (51.6) |
| Mask noninvasive ventilation | 23 (36.5) | 29 (44.6) | 22 (22.9) | 34 (36.6) |
| Standard oxygenc | 5 (7.9) | 8 (12.3) | 16 (16.7) | 11 (11.8) |
| Respiratory rate, median (IQR), breaths/minute | 30 (27, 34) | 30 (28, 34) | 31.5 (27, 35) | 30 (26, 33) |
| Physiologic parameters before enrollment, median (IQR) | ||||
| PaO2 (mmHg) | 57 (51, 66) | 59 (52, 68) | 62 (54, 72) | 62 (55, 72) |
| FiO2 (%) | 80 (70, 100) | 80 (60, 100) | 80 (65, 100) | 70 (60, 90) |
| PaO2/FiO2 ratio | 70 (58, 80) | 68.8 (55, 96) | 77.1 (60.5, 98.6) | 88.8 (64.3, 114.3) |
| PCO2 (mmHg) | 36 (31, 39) | 35 (31, 39) | 35 (32, 39) | 36 (32, 39) |
| HCO3− (meq/L) | 24.1 (21, 27) | 23.7 (22, 25) | 24 (22, 26) | 24 (22, 26) |
| pH | 7.43 (7.40, 7.47) | 7.43 (7.39, 7.47) | 7.44 (7.40, 7.46) | 7.43 (7.40, 7.46) |
| Organ support, N (%) | ||||
| Vasopressors | 8 (12.7) | 2 (3.1) | 5 (5.2) | 9 (9.7) |
| Renal replacement therapy for acute kidney injury | 0 | 1 (1.5) | 0 | 2 (2.2) |
BMI body mass index (calculated as weight in kilograms divided by height in meters squared), FIO2 fraction of inspired oxygen, ICU intensive care unit, IQR interquartile range, SOFA Sequential [Sepsis-related] Organ Failure Assessment
aData on comorbidities were obtained from the medical record. Other comorbidities included mild, moderate, or severe liver disease; chronic neurologic disease, hemiplegia or paraplegia, or dementia; and AIDS/HIV and rheumatologic diseases. Additional details on baseline characteristics are provided in Table S2 in the Online Supplement
bCOVID-19 infection was confirmed by polymerase chain reaction test for SARS-CoV-2 from respiratory specimens. No patients received a diagnosis by rapid antigen test or solely by clinical criteria. After the results of testing were obtained at enrollment, additional patients were confirmed to have COVID-19, totaling 62 of 63 (98.4%) in the helmet noninvasive ventilation group and 65 of 65 (100%) in the the usual respiratory support group among non-survivors and additional patients were confirmed to have COVID-19, totaling 95 of 96 (99%) in the helmet noninvasive ventilation group and 92 of 93 (98.9%) in the usual respiratory support group among survivors
cStandard oxygen included oxygen delivery via any device other than high-flow nasal cannula or noninvasive ventilation regardless of the FiO2 delivered to the patient