NCT07834671

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,232

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Dec 2029

First Submitted

Initial submission to the registry

September 10, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 10, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

ventilator weaningmechanical ventilation

Outcome Measures

Primary Outcomes (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

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 22, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations