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Table 2 Secondary outcomes for the study cohort

From: Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial

Variable Control group Prone group P value
Count 39 36  
Daily total prone time, hours 3.4 [1.8–8.4] 9.0 [4.4–10.6] 0.014
Total protocol duration, days 4.9 [2.3–8.1] 4.2 [1.7–5.7] 0.33
Daily prone time day 1–3, hours 2.6 [0.3–8.1] 8.5 [5.2–12.2] 0.001
30-day mortality 3 (8%) 6 (17%) 0.30
VFDa, all patients, days 30 [11–30] 30 [12–30] 0.69
VFDa, intubated patients, days 2 [1–10] 7 [0–20] 0.38
Days free from HFNO/NIVb 24 [22–26] 26 [23–28] 0.15
Enrolment to IMV, days 2 [1–6] 2 [1–5] 0.59
Use of NIV 27 (69%) 21 (58%) 0.33
Enrolment to NIV, days 0.25 [0.1–1.1] 0.23 [0.05–1.2] 0.63
Admitted to ICU 27 (69%) 27 (75%) 0.58
ICU LOS, days 11 [3–22] 5 [4–13] 0.25
ICU-free daysc 26 [8–30] 25 [14–28] 0.56
Hospital LOS, days 18 [11–30] 16 [11–22] 0.44
Vasoactive drugs 17 (44%) 13 (37%) 0.57
Sedation by continuous infusiond 14 (36%) 16 (44%) 0.45
Renal replacement therapy 1 (3%) 1 (3%)
ECMO 1 (3%) 0 (0%)
WHO clinical progression scale day 7, (0–10) 6 [6, 7] 6 [5–7] 0.35
WHO clinical progression scale, day 30, (0–10) 2 [2–6] 2 [2–4] 0.28
Adverse events
 Pressure sores 9 (23%) 2 (6%) 0.032
 Vomiting during proning 0 (0%) 1 (3%) -
 Central or arterial line dislodgement 0 (0%) 0 (0%) -
 Cardiac arrest within 30 days 1 (3%) 2 (6%) 0.51
 During proning 0 (0%) 0 (0%) -
  1. Categorical parameters are presented as n (%), continuous variables as median (interquartile range [IQR]), VFD, Ventilator-Free Days; HFNO High-flow Nasal Oxygen; NIV, Noninvasive Ventilation; IMV, Invasive Mechanical Ventilation; ICU, Intensive Care Unit; LOS, Length of Stay; ECMO, Extracorporeal Membrane Oxygenation; WHO, World Health Organization
  2. aVentilator-free days were calculated for intubated (Control n = 13, Prone n = 12) and all patients, respectively, and defined as days free from invasive mechanical ventilation from enrollment until day 30. Patients who died were registered as 0 VFD
  3. bPatients who were not intubated. Calculated from enrollment until day 30. Control n = 26, Prone n = 24
  4. cDays when patients were not in the ICU. Patients who died were registered as 0 ICU-free days
  5. dNon-intubated patients during protocol