Actively Recruiting

Age: 18Years +
All Genders
NCT07284888

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

Led by Southeast University, China · Updated on 2026-01-02

1000

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Moderate-to-severe ARDS requiring invasive mechanical ventilation
  • PaO2/FiO2 ratio less than or equal to 150 mm Hg
  • Positive end-expiratory pressure (PEEP) of 5 cm H2O or higher
  • ARDS diagnosed according to the 2023 Global Definition
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China, 210009

Actively Recruiting

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Research Team

H

Hui Chen, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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