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

Table 2 Secondary outcomes for the study cohort

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
VFD^a, all patients, days	30 [11–30]	30 [12–30]	0.69
VFD^a, intubated patients, days	2 [1–10]	7 [0–20]	0.38
Days free from HFNO/NIV^b	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 days^c	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 infusion^d	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%)	-

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
^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
^bPatients who were not intubated. Calculated from enrollment until day 30. Control n = 26, Prone n = 24
^cDays when patients were not in the ICU. Patients who died were registered as 0 ICU-free days
^dNon-intubated patients during protocol

ISSN: 1364-8535