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

Acute Respiratory Distress Syndrome Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• Intensive Care Unit
• Mechanical Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

• NCT number: NCT05056090
• Study type: Interventional
• Source: University Hospital, Grenoble
• Contact: Laura CHAMBON
• Phone: +33476768955
• Email: lchambon@chu-grenoble.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Completion date: March 1, 2024