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RecruitingNCT07519512EARLY-VENTUpdated Apr 23, 2026

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

An interventional study of Early Transition in Mechanical Ventilator Care, sponsored by Southeast University, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Mechanical Ventilator Care
03

In context

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,600 participants (estimated)

Study arms

  • Experimental
    early transition

    Behavioral: Early Transition

  • No intervention
    standard care

Interventions

  • BehavioralEarly Transition

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: the rate of successful extubation at day 28

07

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital, School of Medicine, Southeast University
    Nanjing, Jiangsu 210009, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07519512
Lead sponsor
Southeast University, China
Responsible party
Ling Liu (Prof, Southeast University, China) — Principal investigator
First posted
Apr 9, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 23, 2026

Study contacts

Jie Wu
Contact
1010966339@qq.com
+8615996317013

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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