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Early Versus Deferred De-escalation From Controlled Ventilation After a 48-Hour Landmark of Physiological Stability
Sponsor: Ruijin Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
12736
Start Date
2024-01-01
Completion Date
2026-08-31
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
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.
Locations (1)
Department of Critical Care Medicine，Ruijin Hospital，Shanghai Jiao Tong University School of Medicine，Shanghai，China.
Shanghai, Shanghai Municipality, China