Mechanical Ventilator CareEARLY-VENTNCT07519512
Effect of Early Transition to Assisted Ventilation on 28-day Successful Extubation in Critically Ill Patients
A study testing Early Transition in people with Mechanical Ventilator Care, run by Southeast University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilator Care
- What is being tested?
- Early Transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Jie Wu, +8615996317013, 1010966339@qq.com
About this study
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)
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
- Being tested
- Early Transition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early TransitionBehavioural
Patients are transitioned from controlled to assisted ventilation (preferably Pressure Support Ventilation) within 6 hours of meeting the eligibility criteria
| Study group | Role | What they receive |
|---|---|---|
| early transition | Experimental | Not described Receives: Behavioral: Early Transition |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the rate of successful extubation at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilator CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519512
- Sponsor's protocol ID
- EARLY-VENT
- Acronym
- EARLY-VENT
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07519512
- Acronym / sponsor ID
- EARLY-VENT / EARLY-VENT
- Conditions
- Mechanical Ventilator Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early transition | Experimental | Behavioral: Early Transition |
| standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early TransitionPatients are transitioned from controlled to assisted ventilation (preferably Pressure Support Ventilation) within 6 hours of meeting the eligibility criteria | Behavioural | early transition |
Primary outcome
the rate of successful extubation at day 28
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Transition in people with Mechanical Ventilator Care, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Wu (+8615996317013, 1010966339@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of successful extubation at day 28 (time frame: the rate of successful extubation at day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.