Inferiorly Based Björk Flap and Accidental Decannulation in Surgical Tracheostomy: A Single-Institution Cohort Study...

Objective: Airway emergencies in patients with tracheostomies are life-threatening and may arise from tube obstruction, bleeding, or accidental decannulation owing to improper handling. We describe our institutional experience with measures to prevent accidental decannulation-related emergencies, including the inferior-based tracheal flap technique combined with peri-operative care bundles and its impact on reducing accidental decannulation-related morbidity and mortality. Methods: A retrospective review was conducted on 1485 patients who underwent open tracheostomy at Ajou University Hospital between January 2011 and February 2026. In 2015, a standardized institutional protocol, incorporating the inferior-based tracheal flap as the primary incision technique and a peri-operative care bundle, was introduced following a root-cause analysis. The cohort was divided into pre-protocol (2011-2014; n = 179) and post-protocol (2015-2026; n = 1306) periods, and a long-term-followable analytic subset (Björk flap n = 363; conventional vertical-incision n = 61) was used for per-outcome comparison. These data were integrated with prior comparative studies from the literature in a random-effects meta-analysis; six literature studies plus the institutional cohort were included in the qualitative synthesis, and those with extractable arm-specific event data contributed to the quantitative synthesis. Risk of bias was assessed with ROBINS-I and the Newcastle-Ottawa Scale, and the certainty of evidence was rated using GRADE. Pre-specified sensitivity analyses, including the Hartung-Knapp-Sidik-Jonkman adjustment, were performed. All analyses were performed in R using the metafor package. Results: Pre-protocol, accidental decannulation-related emergencies occurred one to two times per year, including at least one fatal event; post-protocol, only a single event occurred over 12 years, with no associated mortality. In the analytic subset, accidental decannulation occurred in 1/363 Björk patients (0.28%) versus 3/61 conventional patients (4.92%; odds ratio [OR] 0.05, 95% confidence interval [CI] 0.01-0.52). All six pooled meta-analytic domains were directionally favorable to the Björk flap. The primary outcome (accidental decannulation/tube displacement) did not reach statistical significance in the main analysis (pooled OR 0.44, 95% CI 0.03-5.86, p = 0.531, I² = 77%, k = 3). A pre-specified sensitivity analysis excluding İnan 2025 (the heterogeneity-driving outlier) yielded an OR of 0.12 (95% CI 0.02-0.70, p = 0.019, I² = 9%, k = 2); this result is exploratory and hypothesis-generating. Secondary outcomes, including stomal infection (OR 0.26), granulation (OR 0.15), tube blockage (OR 0.21), subcutaneous emphysema (OR 0.38), and bleeding (OR 0.59), all directionally favored the Björk flap. No tracheal stenosis or decannulation failure occurred in either arm of our cohort. Under GRADE, the certainty of evidence was very low for the primary outcome and low for the secondary outcomes. Conclusions: A standardized institutional safety bundle centered on the inferior-based tracheal flap was associated with a low rate of accidental decannulation-related emergencies and no related mortality over a 12-year post-implementation period; because the flap was introduced together with concurrent peri-operative and nursing changes, its independent contribution cannot be isolated. Meta-analytic synthesis showed directionally favorable effects across all complication domains, although the primary outcome reached significance only in an exploratory sensitivity analysis and the overall certainty of evidence was low to very low. These findings are hypothesis-generating and support the inferior-based tracheal flap as a reasonable option within a structured safety bundle for elective surgical tracheostomy, particularly in patients at higher risk for accidental decannulation; prospective comparative studies are warranted.