Table 1.
Baseline Characteristics of Patients and Study Outcomes, According to Study Group
| Characteristic | Helmet CPAP (n = 55) | Facemask CPAP (n = 57) | P Valueda |
|---|---|---|---|
| Age, y | 57 (48-64) | 57 (43-66) | .51 |
| Female, No. (%) | 12 (22) | 20 (35) | .12 |
| APACHE II score | 9 (7-11) | 9 (7-12) | .93 |
| SOFA score | 4 (3-4) | 4 (3-4) | .38 |
| BMI, kg/m2 | 30 (27-34) | 30 (27-35) | .41 |
| Respiratory rate at admission, breaths/min | 28 (25-32) | 30 (26-34) | .16 |
| Spo2/Fio2 at CPAP start | 118 (115-119) | 115 (113-119) | .53 |
| Pao2/Fio2 at CPAP start, % | 96 (89-106) | 101 (87-111) | .25 |
| Paco2 at CPAP start, mm Hg | 34 (33-38) | 34 (32-39) | .84 |
| Comorbidities | |||
| Obesity, No. (%) | 34 (62) | 39 (68) | .46 |
| Hypertension, No. (%) | 11 (20) | 16 (28) | .32 |
| Diabetes, No. (%) | 2 (4) | 6 (11) | .16 |
| COPD, No. (%) | 0 (0) | 2 (4) | .49 |
| Asthma, No. (%) | 2 (4) | 5 (9) | .26 |
| Cardiovascular disease, No. (%) | 1 (2) | 4 (7) | .18 |
| Concomitant medications | |||
| Dexamethasone, No. (%) | 55 (100) | 57 (100) | > .999 |
| Remdesivir, No. (%) | 0 (0) | 2 (4) | .49 |
| Prophylactic anticoagulation, No. (%) | 15 (27) | 12 (21) | .44 |
| Therapeutic anticoagulation, No. (%) | 7 (13) | 4 (7) | .31 |
| Primary outcome | |||
| Endotracheal intubation, No. (%) | 16 (29) | 28 (49) | .029 |
| Time to intubation, d | 3 (2-7) | 1 (1-5) | .18 |
| Reason for intubation | |||
| Signs of respiratory muscles fatigue, No. (%) | 9 (16) | 10 (18) | .87 |
| Hypoxemia, No. (%) | 3 (5) | 10 (18) | .05 |
| Worsening or unbearable dyspnea, No. (%) | 3 (5) | 8 (14) | .13 |
| Pulmonary thromboembolism, No. (%) | 1 (2) | 0 (0) | .49 |
| Secondary outcomes | |||
| PEEP, cm H2O | 14 (12-14) | 10 (10-12) | < .001 |
| Fio2, % | 0.4 (0.4-0.5) | 0.6 (0.4-0.6) | .099 |
| Total hours of CPAP | 211 (130-311) | 151 (42-249) | .009 |
| Respiratory rate at end of CPAP treatment | 22 (19-26) | 25 (22-30) | .002 |
| Spo2/Fio2 at end of CPAP treatment | 251 (189-320) | 187 (150-243) | .001 |
| In-hospital mortality, No. (%) | 10 (18) | 20 (35) | .049 |
| Duration of stay in the hospital, d | 16 (14-25) | 21 (13-29) | .37 |
Results are displayed as median (interquartile range), if not otherwise specified. APACHE II = Acute Physiology and Chronic Health Evaluation II; PEEP = positive end-expiratory pressure; SOFA = Sequential Organ Failure Assessment; Spo2 = oxygen saturation as determined by pulse oximetry.
a
All calculations are unadjusted. Endotracheal intubation and in-hospital mortality were treated as time-to-event data.