Early switch from controlled to assisted ventilation for critically ill adults

Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients: A Multicenter Open-label Randomized Controlled Trial (EARLY-VENT)

This trial will try switching stable adult ICU patients who are on controlled mechanical ventilation to assisted ventilation within 6 hours of eligibility to see if more of them are successfully taken off the ventilator by day 28.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Southeast University, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07519512 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) in the ICU expected to need mechanical ventilation for ≥48 hours who are currently on controlled ventilation, are hemodynamically stable, lightly sedated (RASS ≥ -3), not on neuromuscular blockers, and have a PaO2/FiO2 ≥150 mmHg.

Not a fit: Patients with end-stage irreversible respiratory, cardiac, or neurologic disease likely to require long-term ventilator support, those who are hemodynamically unstable, expected to die or transfer within 48 hours, pregnant patients, or those enrolled in other MV trials are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, earlier transition to assisted ventilation could shorten time on the ventilator and increase the proportion of patients successfully extubated by day 28, potentially lowering ICU complications and length of stay.

How similar studies have performed: Previous randomized and observational studies of earlier spontaneous breathing or assisted modes have shown mixed but sometimes promising reductions in ventilation time, and this larger pragmatic cluster-crossover design seeks more definitive evidence.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Jie Wu

Conditions Mechanical Ventilator Care