ArticleJournal of intensive care2026
Effectiveness of a standardized weaning protocol in tracheostomized patients with prolonged mechanical ventilation: a prospective single-arm interventional trial.
Article in Journal of intensive care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06642714 (Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Early Noninvasive Ventilation and Progressive High-Flow Oxygen Therapy Through a Tracheostomy Tube Weaning Protocol in Tracheostomized Patients With Prolonged Mechanical Ventilation: A Prospective Single-Arm Interventional Study
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9 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients requiring prolonged mechanical ventilation (PMV) after tracheostomy represent a severely deconditioned population with high mortality and substantial healthcare burden. Weaning outcomes vary widely across centers, and evidence supporting standardized protocol in dedicated rehabilitation settings remains limited.
methodsWe conducted a prospective, single-arm interventional trial at a specialized weaning unit (SWU) of a tertiary rehabilitation hospital. From January 2025 to October 2025, consecutive tracheostomized PMV patients were enrolled and managed with a standardized stepwise weaning protocol integrating spontaneous breathing trials, high-flow oxygen therapy, and noninvasive ventilator. The primary outcome was the 60-day weaning success rate, which was tested against a pre-specified historical benchmark (p₀ = 65%) using exact binomial, score-based, and Katz log-method analyses. Secondary outcomes included 6-month mortality, analyzed through modified Poisson regression with propensity score matching and overlap weighting. An individualized calculated weaning score was developed using LASSO-Poisson regression with log(p₀) as an offset to elucidate the heterogeneity in treatment response.
resultsWeaning success was achieved in 189 of 250 patients (75.6%; 95% CI 69.9-80.5%), significantly exceeding the historical benchmark (RR, 1.16; 95% CI 1.08-1.25; p < 0.001). Mean weaning duration was 19.9 ± 10.0 days; 30-day reconnection occurred in 2.1% of successfully weaned patients. Six-month mortality was 14.4% and was lower among successfully weaned patients (9.0% vs 31.1%) with confounding and limited event numbers precluding a definitive causal inference. Tertile stratification by the calculated weaning score revealed a monotonic gradient in weaning success (T1, 44.0%; T2, 84.3%; T3, 98.8%; trend p < 0.001). The tool was deployed online at https://jianghongying.shinyapps.io/Weaning-for-PMV/ .
conclusionsA standardized weaning protocol delivered in a dedicated rehabilitation unit was associated with a 60-day weaning success rate that exceeded a pre-specified historical benchmark in PMV patients. The individualized calculated weaning score identifies clinical phenotypes for individualized decision-making; the accompanying web-based calculator is provided as an exploratory research tool and warrants external validation before any routine clinical application.
trial registrationClinicalTrials.gov, NCT06642714.
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