An observational study in Critical Illness, Respiratory Failure and Mechanical Ventilation, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Ruijin Hospital · Observational
This retrospective target trial emulation evaluates the optimal timing of de-escalation from controlled to assisted mechanical ventilation in critically ill adults. Using the clone-censor-weight (CCW) estimator with stabilised inverse-probability-of-censoring weights, we compare two strategies over a 24-hour grace window following a 48-hour landmark: early de-escalation (step-down in ventilatory support mode or successful extubation) versus deferred de-escalation (support maintained or increased). The primary outcome is 28-day in-hospital mortality. Secondary outcomes are 28-day restricted mean survival time (RMST) and ventilator-free days (VFD28). The study uses MIMIC-IV v2.2 (derivation cohort, n=1,902 analysable) with external validation in eICU-CRD v2.0 (validation cohort, n=10,957 analysable). All analyses employ stabilised IPCW with bootstrap confidence intervals, including six sensitivity and robustness analyses (extended covariate adjustment, alternative weight truncation, doubly robust AIPW estimator) and an exploratory FiO₂×PEEP threshold grid.
Background: Mechanical ventilation is life-saving, yet optimal timing of transition from controlled to assisted modes remains uncertain. Prolonged controlled ventilation exposes patients to sedation, diaphragm dysfunction, and lung injury, while premature de-escalation risks asynchrony and reintubation.
Design: Landmark target trial emulation with 48-hour eligibility ascertainment.
Eligibility: Adults ≥18 years, invasive mechanical ventilation >24 hours, alive and ventilated at 48 hours with classifiable Day-2 mode (controlled or assisted), Day-2 FiO₂ ≤50%, Day-2 PEEP ≤10 cmH₂O.
Strategies: Early-support level decreased by Day 3 (mode step-down from controlled to assisted, or successful extubation while alive); Deferred-support maintained or increased.
Analysis: Single-interval CCW estimator with stabilised IPCW (truncated 1st-99th percentile), propensity model with 21 baseline covariates, bootstrap 95% CIs (2,000 resamples primary; 800 sensitivity). Sensitivity analyses: no truncation, ICU mortality, unweighted per-protocol, extended 40-covariate adjustment, 5th-95th truncation, AIPW doubly robust estimator. E-values computed for unmeasured confounding.
External validation: Harmonised protocol in eICU-CRD v2.0 (208 hospitals, n=10,957), outcome: in-hospital mortality.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 12,736 is above the median of 140 across 814 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Compared within Critical Illness, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Adults admitted to the intensive care unit (ICU) receiving invasive mechanical ventilation who are alive and ventilated at the 48-hour landmark with low respiratory support requirements (FiO₂ ≤50%, PEEP ≤10 cmH₂O).
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Exclusion Criteria:
Step-down in ventilatory support level by Day 3 (transition from controlled to assisted/spontaneous mode, or successful extubation with recorded end of mechanical ventilation while alive)
Other: Ventilatory Support De-escalation Strategy
Ventilatory support level maintained or increased between Day 2 and Day 3
Other: Ventilatory Support De-escalation Strategy
The study compares two respiratory support management strategies over a 24-hour grace window (Day 2 to Day 3 of ICU admission) following the 48-hour landmark. Early De-escalation: Ventilatory support level is decreased, defined as a transition from a controlled mode to an assisted/spontaneous mode, or successful extubation (end of mechanical ventilation) while the patient is alive by Day 3. Deferred De-escalation: Ventilatory support level is maintained or increased between Day 2 and Day 3.
28-Day In-Hospital Mortality
Death in hospital within 28 days of ICU admission
Time frame: within 28 days of ICU admission
28-Day Restricted Mean Survival Time (RMST)
Mean survival time up to 28 days
Time frame: within 28 days of ICU admission
Ventilator-Free Days at Day 28 (VFD28)
Number of days alive and free of mechanical ventilation within the first 28 days; set to zero for patients who died before day 28
Time frame: within 28 days of ICU admission
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Ran from Jan 2024 to primary completion in Dec 2025, 23 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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