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NCT Number: NCT07284888

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

Treatment and study plan

Prone Position Ventilation

Other

Patients underwent prone positioning while receiving invasive mechanical ventilation

Primary outcomes

  1. 60-day mortality

    Time frame: From inclusion to 28 days

    The proportion of patients who are died within 60 days

Secondary outcomes

  1. 28-day mortality

    Time frame: From inclusion to 28 days

    The proportion of patients who are died within 28 days

  2. Ventilator-free days at 28 days

    Time frame: From inclusion to 28 days

    Days alive without endotracheal intubation and invasive mechanical ventilation

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Chen, MD

CONTACT

[email protected]

+8618006138640

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Acronym: PPV SAFE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 16, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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