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EARLY-VENT is a multicenter, open-label, three-period cluster-randomized crossover trial designed to evaluate whether early transition from controlled to assisted ventilation improves outcomes in critically ill patients. The study will enroll approximately 1,600 adult patients across 10 ICUs who are expected to require mechanical ventilation for at least 48 hours and meet specific stability criteria (e.g., hemodynamically stable, light sedation). Participating centers will alternate between an experimental strategy, where patients transition to an assisted mode (preferably Pressure Support Ventilation) within 6 hours of eligibility, and a control strategy based on standard care practices. The primary endpoint is the rate of successful extubation at day 28, aiming to demonstrate that transition from controlled to assisted ventilation can reduce ventilation duration and improve prognosis compared to delayed transition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early transition | Experimental |
| |
| standard care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Transition | Behavioral | Patients are transitioned from controlled to assisted ventilation (preferably Pressure Support Ventilation) within 6 hours of meeting the eligibility criteria |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of successful extubation at day 28 |
| the rate of successful extubation at day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Written informed consent not obtained.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wu | Contact | +8615996317013 | 1010966339@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, School of Medicine, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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