Early awake prone positioning combined with non-invasive oxygen therapy in patients with COVID-19

Adaptive, multicenter, randomized, controlled, open trial of the use of early prone positioning in conscious patients with severe COVID-19 without invasive ventilatory support, to prevent invasive mechanical ventilation and death. - Adaptive, multicenter, randomized, controlled, open trial of the use of early prone positioning in conscious patients with severe COVID-19 without invasive ventilatory support, to prevent invasive mechanical ventilation and death (APPearl)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045889

Enrollment

384

Registered

2021-10-27

Start date

2021-09-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, acute hypoxemic respiratory failure

Interventions

Intervention - Awake prone positioning. The intervention consists of self- or assisted positioning in the decubitus recumbent prone position (bed header at 0 grades) for as much as possible, with the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient hospitalized in non-critical wards, with at least 12 hours of hospital stay but no longer than 48 hours at the moment of randomization. 2. Severe COVID-19 according to the following criteria: a. Symptoms of COVID-19, with 1 or more of the following i. Tachypnea (greater than or equal to 30 breaths per minute) ii. Peripheral oxygen saturation (SpO2) at room air (FiO2 21%) lower than or equal to 93% at sea level (lower than or equal to 89% in Mexico City) at any moment of current hospitalization. iii. PaO2/FiO2 ratio <300 iv. Pulmonary infiltrates >50% in imaging study performed in the last 24 to 48 hours. 3. Oxygen therapy with a device providing a FiO2 greater than or equal to 40% a. Low-flow nasal cannula with at least 5 liters per minute. b. Non-rebreather mask c. High-flow nasal cannula without imminent requirement of orotracheal intubation (ROX index greater than or equal to 4.88) 4. The participant understands the intervention, randomization, follow-up and provides their written informed consent prior to randomization.

Exclusion criteria

Exclusion criteria: 1. Patients in palliative care 2. Patients with imminent orotracheal intubation according to refractory hypoxemia with acute respiratory distress syndrome (ARDS), acute respiratory acidosis (pH < 7.15, PaCO2 >45 mmHg) with ARDS, requirement of airway protection. 3. Patients with unsolved shock (reanimation phase or norepinephrine dose greater than or equal to 0.15 mcg/kg/min). 4. Unstable arrythmias (bradycardia o tachycardia). 5. Mental agitation or altered mental state (Glasgow Comma Scale <10 points) that would impede cooperation to self-prone. 6. Instability of the pelvis, vertebral column, or femur due to recent surgery or trauma. 7. Anatomical alterations that limit the adoption of prone position (severe kyphoscoliosis, muscle contracture, or other). 8. Abdominal surgery in the last 15 days. 9. Thoracic lesion or surgery in the last 15 days. 10. Pregnancy 11. Intracranial hypertension 12. Deep vein thrombosis in the last 2 days. 13. Heart pacemaker surgery in the last 2 days. 14. Chest tube with air leak 15. Recent facial trauma or surgery 16. Morbid obesity (BMI >40 kg/m2) 17. Pressure lesions or ulcers

Design outcomes

Primary

Measure	Time frame
1.Proportion of patients with orotracheal intubation and invasive mechanical ventilation performed up to 28 days after randomization. 2.Proportion of patients who die up to 28 days after randomization.	—

Secondary

Measure	Time frame
1. Probability of transition and occupation of 4 clinical states (non-invasive oxygen therapy, invasive mechanical ventilation, domiciliary discharge, and death) up to day 28 after randomization. 2. Proportion of patients achieving a SpO2/FiO2 greater than or equal to 236 for at least 12 hours within 28 days after randomization. 3. Proportion of patients achieving the greater than or equal to 12 hours/day in the prone position during the duration of the intervention, up to 28 days after randomization 4. SpO2/FiO2 index at different times (Baseline, 1 hour, 6 hours, 24 hours, 48 hours, and 72 hours). 5. Proportion of patients with complications potentially associated to prone position (accidental vascular access dislodgement, vomit, falls, pressure lesions, and intolerance to prone position) up to 28 days after randomization 6. Proportion of patients who develop acute respiratory distress syndrome (up to 28 days after randomization). 7. Proportion of patients with de novo organic failure during hospital stay (up to 28 days after randomization). 8. Time (days) of hospital stay (up to 28 days after randomization). 9. Time (days) of stay in the intensive care unit (up to 28 days after randomization). 10. Total time (days) of invasive mechanical ventilation (up to 28 days after randomization). 11. Total time (days) of ventilator-free days (up to 28 days after randomization).	—

Measure

Time frame

1. Probability of transition and occupation of 4 clinical states (non-invasive oxygen therapy, invasive mechanical ventilation, domiciliary discharge, and death) up to day 28 after randomization. 2. Proportion of patients achieving a SpO2/FiO2 greater than or equal to 236 for at least 12 hours within 28 days after randomization. 3. Proportion of patients achieving the greater than or equal to 12 hours/day in the prone position during the duration of the intervention, up to 28 days after randomization 4. SpO2/FiO2 index at different times (Baseline, 1 hour, 6 hours, 24 hours, 48 hours, and 72 hours). 5. Proportion of patients with complications potentially associated to prone position (accidental vascular access dislodgement, vomit, falls, pressure lesions, and intolerance to prone position) up to 28 days after randomization 6. Proportion of patients who develop acute respiratory distress syndrome (up to 28 days after randomization). 7. Proportion of patients with de novo organic failure during hospital stay (up to 28 days after randomization). 8. Time (days) of hospital stay (up to 28 days after randomization). 9. Time (days) of stay in the intensive care unit (up to 28 days after randomization). 10. Total time (days) of invasive mechanical ventilation (up to 28 days after randomization). 11. Total time (days) of ventilator-free days (up to 28 days after randomization).

—

Countries

North America,South America

Contacts

Public ContactJose Vidal-Mayo

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Intensive Care Unit

interstrok@hotmail.com+52(55)48158075

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026