Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Early Transition: Patients are transitioned from controlled to assisted ventilation (preferably Pressure Support Ventilation) within 6 hours of meeting the eligibility criteria

Study summary

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.

Eligibility

Primary outcome measure(s)

• the rate of successful extubation at day 28 — the rate of successful extubation at day 28
  1. No re-intubation or death occurred for 7 consecutive days after extubation, or the patient survived ICU admission with non-invasive mechanical ventilation within 7 days post-extubation-whichever occurs first. 2. For tracheostomy patients: Successful extubation is defined as achieving spontaneous ventilation through the tracheostomy for seven consecutive days without any form of assisted ventilation, or discharge from the ICU without assisted respiratory support, whichever occurs first.

Trial sites (1)

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