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NCT Number: NCT07519512

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

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.

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Key information

Conditions

Mechanical Ventilator Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Jie Wu

CONTACT

[email protected]

+8615996317013

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Transition

Behavioral

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

Primary outcomes

  1. the rate of successful extubation at day 28

    Time frame: the rate of successful extubation at day 28

    • 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.
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Wu

CONTACT

[email protected]

+8615996317013

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study 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)

Acronym: EARLY-VENT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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