Effectiveness of a standardized weaning protocol in tracheostomized patients with prolonged mechanical ventilation: a prospective single-arm interventional trial

Abstract

Patients 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. We 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. Weaning 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/ . A 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. ClinicalTrials.gov, NCT06642714.