NCT07519512

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mechanical Ventilator Care

Interventions

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

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: China