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Acute Respiratory FailureNCT07834671

Research on Respiratory Support Decision-Making for Mechanically Ventilated ICU Patients Based on a Physiological World Model

An observational study of Acute Respiratory Failure, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

Mechanical ventilation is essential for ICU patients with respiratory failure, yet ventilator adjustment and weaning decisions remain experience-dependent and highly variable. Current single-point metrics such as the oxygenation index cannot distinguish true recovery from support-dependent stability-the same… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Failure
How many people
4,232 participants
Where
1 siteChina
Study dates
14 Sep 2026to 31 Dec 2029
Phase
Observational

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

Study population: Adult ICU patients (≥18 years) who received invasive mechanical ventilation at the Department of Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, between January 2016 and June 2026.

Who may be able to join

  • age ≥ 18 years
  • received invasive mechanical ventilation during ICU stay
  • had complete 48hour baseline data and 96hour followup data.

Who cannot join

  • age < 18 years
  • duration of mechanical ventilation < 24 hours
  • missing rate > 50% for key variables (FiO₂, PEEP, SpO₂, respiratory rate)
  • received ECMO therapy.

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
  • Ruijin hospital

    Shanghai, Shanghai Municipality, 200025

    Jing Xu, +8618217732985, xj40952@rjh.com.cn

Other trials in China

About this study

Mechanical ventilation is essential for ICU patients with respiratory failure, yet ventilator adjustment and weaning decisions remain experience-dependent and highly variable. Current single-point metrics such as the oxygenation index cannot distinguish true recovery from support-dependent stability-the same oxygenation level may reflect either. This study uses EHR data from 4,232 invasively ventilated ICU patients at Ruijin Hospital (2016-2026) to develop LAVENT, a deep learning-based physiological world model of respiratory dynamics. LAVENT learns the co-evolution of patient physiology and respiratory support, generates 96-hour multivariate trajectories under candidate FiO₂/PEEP settings, and compares alternative ventilation strategies within the same patient state. External validation uses the MIMIC-IV database (n = 29,899). This retrospective observational study uses only existing EHR data, with no prospective intervention or biospecimen collection.

Read the detailed description

Mechanical ventilation is the cornerstone of life support for critically ill patients with respiratory failure in the ICU. However, adjustments to ventilator settings and decisions regarding weaning remain highly dependent on clinical experience, resulting in substantial inter-clinician variability. A fundamental limitation of current practice is that commonly used single-point metrics-such as the oxygenation index-cannot reliably reflect a patient's true recovery state across different levels of respiratory support. The same oxygenation level may indicate genuine recovery in a patient on low support, or persistent respiratory failure masked by high ventilatory support. This conflation of "true recovery" with "support-dependent stability" is a major contributor to weaning failure and delayed extubation.

To address this challenge, this study will leverage electronic health record (EHR) data from ICU patients who received invasive mechanical ventilation at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, between 2016 and 2026 (RuiICU-P1 cohort, n = 4,232), to develop a deep learning-based physiological world model of respiratory dynamics (LAVENT). The model is designed to: (1) learn the co-evolutionary dynamics between a patient's physiological state and respiratory support; (2) generate 96-hour multivariate clinical trajectories given the current patient state and candidate ventilator settings (FiO₂, PEEP); and (3) compare the differential clinical outcomes of alternative ventilator adjustment strategies within the same patient state. External validation will be performed using the public MIMIC-IV database (n = 29,899) to assess model transferability across healthcare systems.

This is a retrospective, observational study using only existing EHR data, without any prospective patient intervention, additional examinations, or biospecimen collection.

Keywords
ventilator weaning, mechanical ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. success rate of ventilator weaning

    The proportion of participants who successfully achieve liberation from invasive mechanical ventilation (weaning success), expressed as a percentage of all participants who undergo a weaning attempt

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start14 Sep 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
4,232 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07834671
Sponsor's protocol ID
RJ2026681
Status last verified
Sep 2026
First submitted
10 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Privacy and confidentiality constraints: The source data contain sensitive clinical information derived from electronic medical records. Although all data are de-identified before analysis, the combination of detailed longitudinal physiological variables, ventilator parameters, and clinical outcomes carries a residual risk of re-identification. Institutional privacy policies and the approved ethics protocol do not permit public deposition of individual-level data. Ethics approval and consent limitations: This study is approved with a waiver of informed consent for retrospective use of existing EHR data. The ethics approval covers secondary analysis for the specified research purpose only, and does not extend to unrestricted sharing or redistribution of individual-level records.

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