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

NCT07519512 | Recruiting DMC

• 1 other identifier: EARLY-VENT
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  the rate of successful extubation at day 28

Study Arms (2)

early transition

EXPERIMENTAL

Behavioral: Early Transition

standard care

NO INTERVENTION

Interventions

Early Transition BEHAVIORAL

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

early transition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Central Study Contacts

Jie Wu

CONTACT

+8615996317013; 1010966339@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)