Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Transition.
- Who it may be relevant to
- Registry conditions: Mechanical Ventilator Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Interventions
- Behavioral Early Transition
Patients are transitioned from controlled to assisted ventilation (preferably Pressure Support Ventilation) within 6 hours of meeting the eligibility criteria
Primary outcome measures
- the rate of successful extubation at day 28 [Time frame: the rate of successful extubation at day 28]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongda Hospital, School of Medicine, Southeast University — Nanjing
Identifiers
NCT: NCT07519512 · EARLY-VENT