NCT05056090

Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 656 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively. Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics. A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 \<150 mmHg, when neuromuscular blockade and long prone positioning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 \<150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS. There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg: 1. There is no trial that has specifically tested PP in this ARDS subset; 2. PP is safe and has become a standard of care in ICU; 3. Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients; 4. The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages; 5. Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively. 6. Finally, PP has been shown to be cost-effective under commonly accepted thresholds. The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.

Conditions

• ARDS
• Acute Respiratory Distress Syndrome
• Intensive Care Unit
• Mechanical Ventilation

Interventions

Type	Name	Description
PROCEDURE	Patients will receive MV in PP	Putting the patient in a prone position

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-09-28
• Completion: 2024-03-01
• First posted: 2021-09-24
• Last updated: 2022-11-07

Locations

1 site across 1 country: France