Early switch from controlled to assisted ventilation for critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EARLY-VENT is a multicenter, open-label, three-period cluster-randomized crossover trial enrolling about 1,600 adults across 10 ICUs. Participating ICUs alternate between an experimental strategy, in which eligible patients are transitioned to an assisted mode (preferably Pressure Support Ventilation) within 6 hours, and a control strategy reflecting local standard care. Eligible patients are adults expected to require mechanical ventilation ≥48 hours who are hemodynamically stable, lightly sedated (RASS ≥ -3), not receiving neuromuscular blockers, and have a P/F ratio ≥150 mmHg. The primary outcome is the proportion of patients successfully extubated by day 28, with the goal of reducing ventilation duration and improving prognosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Expected ICU stay and mechanical ventilation (MV) ≥ 48 hours.
* Currently receiving controlled ventilation mode
* No neuromuscular blocking agents in use, and sedation level RASS ≥ -3.
* P/F ≥ 150 mmHg.

Exclusion Criteria:

* Severe end-stage irreversible respiratory, cardiac, or neurologic disease that may lead to long-term/chronic ventilator dependence or inability to wean from MV (e.g., interstitial lung disease/pulmonary fibrosis, cardiomyopathy, valvular disease, severe traumatic brain injury, Guillain-Barré syndrome, amyotrophic lateral sclerosis, multiple sclerosis, high cervical spinal cord injury, or other restrictive diseases).
* Expected death or transfer out of the ICU within 48 hours.
* Hemodynamic instability judged by the treating clinician.
* Pregnancy.
* Currently participating in other clinical studies related to mechanical ventilation.
* Any other condition considered unsuitable for participation by the investigator.

Written informed consent not obtained.

Where it's running

• Zhongda Hospital, School of Medicine, Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jie Wu
• Email: 1010966339@qq.com
• Phone: +8615996317013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.