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Early Versus Deferred De-escalation From Controlled Ventilation After a 48-Hour Landmark of Physiological Stability

NCT07804992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12736

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804992 on ClinicalTrials.gov