Prospective validation of a non-invasive bedside protocol for tracheostomy decannulation in acquired brain injury with otolaryngologic concordance

BACKGROUND: Decannulation of tracheostomy in individuals with acquired brain injury (ABI) is challenging and often requires endoscopic airway assessment. A reliable noninvasive bedside protocol could support decision-making in neurorehabilitation settings. METHODS: We conducted a prospective observational cohort study at a tertiary neurorehabilitation center between July 2021 and March 2025. Thirty-six adults with chronic ABI and tracheostomies were assessed using a structured bedside protocol comprising tracheostomy capping tolerance, suction requirement ≤2 episodes per 24 hours, modified Evans blue dye aspiration screening, and laryngeal ultrasonography. All participants subsequently underwent blinded nasopharyngolaryngoscopic (NPL) examination as the reference standard. RESULTS: Twenty-six participants (72.2%) were protocol positive; 24 were suitable for decannulation on NPL and two were unsuitable. Among 10 protocol-negative participants, nine were unsuitable and one was suitable. Sensitivity was 96.0% (95% CI 79.6-99.9), specificity 81.8% (95% CI 48.2-97.7), and overall accuracy 91.7%. Agreement with NPL findings was strong (κ = 0.80). No aspiration pneumonia, respiratory deterioration, or recannulation occurred during four weeks of follow-up. CONCLUSIONS: The bedside protocol may serve as a screening tool to support decannulation assessment and guide the need for confirmatory endoscopic evaluation. Larger multicentre studies are warranted.