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

Acute respiratory distress syndrome (ARDS) is a major cause of mortality in intensive care units. Prone position ventilation (PPV) is an important component of ARDS management and has been shown to reduce mortality in patients with moderate-to-severe ARDS. However, substantial heterogeneity exists in treatment response to PPV. Previous studies suggest that lung morphology-focal versus non-focal patterns based on chest CT-may influence responses to ventilatory strategies, but whether lung morphology modifies the effect of PPV remains unclear. In addition, the benefits and safety of PPV in patients with acute brain injury (ABI) complicated by ARDS are uncertain. Although PPV improves oxygenation, it may impair cerebral venous drainage and increase intracranial pressure, raising concerns about its use in ABI patients. Evidence from randomized trials in this population is limited and excludes patients with more severe hypoxemia or elevated intracranial pressure.

Furthermore, the optimal duration and termination criteria for PPV are not well established. While PPV improves alveolar recruitment and reduces ventilator-induced lung injury, prolonged PPV may lead to excessive sedation exposure and PPV-related complications. Identifying the appropriate timing to discontinue PPV may help balance clinical benefits and potential harms.This study is a prospective, multicenter registry enrolling patients with moderate-to-severe ARDS. The objectives are: (1) To determine whether lung morphology can guide individualized PPV strategies; (2) To evaluate the effectiveness and safety of PPV in patients with ARDS complicated by acute brain injury; (3) To investigate the optimal timing for termination of PPV through target trial emulation methods.In addition to these core objectives, the study will include other exploratory aims.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Prone position ventilation

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hui Chen, MD; Phone Number: +8618006138640; Email: huichen.icu@gmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, School of Medicine, Southeast University
      • Contact: Hui Chen; Phone Number: +86-18006138640; Email: 15905162429@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Moderate-to-severe ARDS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS patients received PPV	Other: Prone position ventilation; Patients underwent prone positioning while receiving invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day mortality	The proportion of patients who are died within 60 days	From inclusion to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	The proportion of patients who are died within 28 days	From inclusion to 28 days
Ventilator-free days at 28 days	Days alive without endotracheal intubation and invasive mechanical ventilation	From inclusion to 28 days

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: PPV in ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No