NCT07284888 Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry-Based Observational Study
| NCT ID | NCT07284888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southeast University, China |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07284888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07284888 currently recruiting?
Yes, NCT07284888 is actively recruiting participants. Contact the research team at huichen.icu@gmail.com for enrollment information.
Where is the NCT07284888 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07284888 clinical trial?
NCT07284888 is sponsored by Southeast University, China. The trial plans to enroll 1,000 participants.