Prone positioning for adults with moderate-to-severe ARDS in the ICU

Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study

This study will see how prone positioning ventilation works for adults with moderate-to-severe ARDS and whether it is safe for people who also have acute brain injury.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Southeast University, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07284888 on ClinicalTrials.gov

What this trial studies

Researchers will use a registry-based observational approach at a single tertiary hospital to collect clinical data on adults with moderate-to-severe ARDS receiving invasive mechanical ventilation. Eligible patients meet PaO2/FiO2 ≤150 mm Hg, PEEP ≥5 cm H2O, and ARDS defined by the 2023 Global Definition. The study will describe practice patterns, patient outcomes, and safety signals with prone position ventilation, and will explore whether chest CT–defined lung morphology (focal vs non-focal) modifies response. As an observational, single-center investigation, it will report associations and hypothesis-generating findings rather than prove causation.

Who should consider this trial

Good fit: Adults (≥18 years) with moderate-to-severe ARDS on invasive mechanical ventilation—defined by PaO2/FiO2 ≤150 mm Hg, PEEP ≥5 cm H2O, and the 2023 ARDS criteria—are the intended participants.

Not a fit: Patients with mild ARDS who are not invasively ventilated, those who decline consent, or people treated outside the participating hospital are unlikely to gain benefit from enrolling.

Why it matters

Potential benefit: If successful, the study could help clinicians identify which ARDS patients benefit most from prone ventilation and clarify safety for those with acute brain injury.

How similar studies have performed: Randomized trials have shown that prone ventilation reduces mortality in moderate-to-severe ARDS, but its variation by lung morphology and its safety in acute brain injury remain unclear.

Eligibility criteria

Inclusion Criteria:

1.Age ≥ 18 years 2. Moderate-to-severe ARDS requiring invasive mechanical ventilation, defined as:

1. PaO₂/FiO₂ ≤ 150 mm Hg,
2. PEEP ≥ 5 cm H₂O,
3. ARDS diagnosed according to the 2023 Global Definition.

Exclusion Criteria:

1.Refusal of informed consent by the patient's legally authorized representative

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Hui Chen, MD

Conditions Acute Respiratory Distress Syndrome