Ehrmann et al (2021)
11
- Ehrmann S
- Li J
- Ibarra Estrada M
- et al.
Awake prone positioning for COVID-19 acute hypoxemic respiratory failure: a randomized, controlled, multinational, open-label meta-trial.
|
United States, Mexico, Canada, Ireland, France and Spain |
Multicenter RCT |
Intensive care unit, intermediate care unit, emergency department and general services |
564 participants were given an awake prone position for as long and as frequently as possible; median daily duration 5 0 h (IQR 1 6–8 8) plus usual care |
557 participants received usual care (HFNC) |
Treatment failure within 28 days of enrollment, defined as intubation or death |
28 days |
intubation; mortality; use of the NAV; length of hospital stay; time to HFNC withdrawal in patients who have succeeded in treatment; duration of IMV in intubated patients surviving to day 28; mortality in IMV patients; predefined security results; physiological response to awake prone positioning, including ROX index |
Taylor et al (2021)
12
- Taylor SP
- Bundy H
- Smith WM
- Skavroneck S
- Taylor B
- Kowalkowski MA
Awake-prone positioning strategy for non-intubated hypoxic patients with COVID-19: a pilot trial with integrated implementation evaluation.
|
United States |
Monocentric RCT |
General room |
27 participants received an awake prone position plus usual care |
13 received usual care (room air, nasal cannula, HFNC or NIV) |
Results relating to the successful implementation of a future definitive RCT |
Until discharge or death |
S/F; time on S/F 6 L/min; intubation; length of hospital stay; hospital mortality at 48 hours; safety results |
Johnson et al (2021)
13
- Johnson SA
- Hortons DJ
- More complete MJ
- et al.
Patient-directed prone positioning in awake COVID-19 patients requiring hospitalization (PAPR).
|
United States |
Monocentric RCT |
General room |
15 participants received awake prone positioning every 4 h, lasting 1–2 h or as long as tolerated; median total duration 1 6 h (IQR 0 2–3 1) plus usual care |
15 participants received usual care (room air or nasal cannula) |
Change of P/F at 72 h after admission |
28 days |
The change of P/F at 48 h; the need for endotracheal intubation; transfer to intensive care; escalation in the oxygen delivery system; the duration of the stay; duration of stay ; ventilator-free days; hospital mortality |
Rosen et al (2021)
14
- Rosen J.
- von Oelreich E
- Fors D
- et al.
Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial.
|
Sweden |
Multicenter RCT |
USI and general room |
36 participants received an awake prone position for at least 16 h/day; median daily duration 9 0 h (IQR 4 4–10 6) plus usual care |
39 participants received usual care (HFNC or NIV) |
Intubation within 30 days of enrollment |
30 days |
Duration of awake prone positioning; use of the NAV; NIV delay for patients included with HFNC; use of vasopressors or inotropes; CRRT; ECMO; ventilator-free days; days without VIN or HFNC; length of stay in hospital and intensive care; 30-day mortality; WHO ordinal scale for clinical improvement at 7 and 30 days; adverse events |
Kharat et al (2021)
15
- Kharat A
- Dupuis-Lozeron E
- Singer C
- et al.
Self-pronation in COVID-19 patients on low-flow oxygen therapy: a cluster-randomised controlled trial.
|
Switzerland |
Monocentric RCT |
General room |
10 participants received an awake prone position, self-pronation for 12 h/day, and alternate body position every 4 h; median total duration 4 9 h (SD 3 6) plus usual care |
17 participants received usual care (nasal cannula) |
Oxygen requirements assessed by nasal cannula oxygen flow at 24 h |
28 days |
S/F ratio at 24 h; 24-hour respiratory and heart rate; patient trajectory (transfer to intensive care unit) and potential adverse effects related to the procedure as defined by neck pain; positional discomfort and gastroesophageal reflux; intubation; dead at 28 days |
Jayakumar et al (2021)
16
- Jayakumar D
- Ramachandran Dnb P
- Rabindrarajan Dnb E
- Vijayaraghavan MD BKT
- Ramakrishnan Ab N
- Venkataraman Ab R
Standard care versus awake prone position in non-intubated adult patients with acute hypoxemic respiratory failure secondary to COVID-19 infection – a multicenter feasibility randomized controlled trial.
|
India |
Multicenter RCT |
intensive care |
30 participants received awake prone positioning for at least 6 h/day plus usual care |
30 participants received usual care (nasal cannula, face mask, mask without rebreather, HFNC or NIV) |
The proportion of patients adhering to the protocol |
Until discharge or death |
Proportion of patients requiring increased respiratory support; number of hours lying down and maximum hours of continuous prone positioning in a day; length of stay in intensive care; ICU mortality; adverse events |
Gad et al (2021)
17
Awake prone positioning versus noninvasive ventilation for COVID-19 patients with acute hypoxemic respiratory failure.
|
Egypt |
Monocentric RCT |
intensive care |
15 participants received awake prone positioning for 1-2 h each session 3 h apart during waking hours for the first 3 days plus usual care |
15 participants received usual care (mask without rebreather) |
Improvement of oxygenation and avoidance of intubation in the first 3 days after admission to intensive care |
.. |
Stay in intensive care and stay in hospital |
Fralick et al (2021)
18
- Fralick M
- Colacci M
- Munshi L
- et al.
Prone Positioning of Patients with Moderate Hypoxia Due to COVID-19: A Multicenter Pragmatic Randomized Trial [COVID PRONE].
|
Canada, United States |
Multicenter RCT |
General room |
126 participants received an awake prone position four times a day (up to 2 h for each session) and they were encouraged to sleep in the prone position at night; median total duration 6 h (IQR 1 5–12 8) in the first 72 h and 0 h (IQR 0–12) from 72 h to 7 days; plus usual care |
122 participants received usual care (nasal prong, venturi mask, HFNC) |
A composite of in-hospital death, mechanical ventilation, or worsening respiratory failure defined as requiring at least 60% fractional inspired oxygen for more than 24 h |
30 days |
Components of the composite analyzed individually; time spent lying down; change of S/F; recovery time (defined as being in room air for at least 24 h); time to discharge from hospital; and the rate of serious adverse events |
Garcia et al (2021)
19
- Garcia MA
- Rampon GL
- Doros G
- et al.
Rationale and design of the awake prone position for early hypoxemia in the COVID-19 study protocol (APPEX-19).
|
United States |
Multicenter RCT |
General room |
159 participants received awake prone positioning in up to four daily 1–2 h sessions, and up to 12 h at night plus usual care |
134 participants received usual care (room air, nasal cannula, mask or HFNC) |
Progression of acute respiratory failure, composite outcome of either respiratory deterioration (i.e., progression to mask without rebreather, HFNC, NIV, IMV, or requiring oxygen boost ≥ 2 L/min compared to their initial value) or admission to the ICU |
14 days (or until discharge or death) |
Respiratory deterioration; admission to ICU; receipt of IMV; hospital mortality; diagnosis of ARDS; self-reported median dyspnea (Borg score); safety results; and respect for the awake positioning on the stomach |
Harris et al (NCT04853979) |
Qatar |
Multicenter RCT |
General room |
31 participants received awake prone positioning for at least 3 h/day and up to 16 h/day plus usual care |
30 participants received usual care (nasal cannula, mask without rebreather, HFNC or NIV) |
Escalation of respiratory support within 30 days of study |
30 days |
Incidence of intubation within 30 days of enrollment; use of nasal prongs, Hudson mask, mask without rebreather, NIV and IMV in each group during the first 3 days of the study; physiological response to the mean supine position on days 1-3; P/F or S/F ratio and ROX index at baseline, 1 hour after the first prone position and daily for 4 days; tilt tolerance time; 28-day mortality; length of stay in intensive care unit and hospital; duration of IMV; moving devices; adverse events |