Prospective Validation of a Non-Invasive Bedside Protocol for Tracheostomy Decannulation in Acquired Brain Injury With Otolaryngologic Concordance

Title Dataset for: Prospective Validation of a Non-Invasive Bedside Protocol for Tracheostomy Decannulation in Acquired Brain Injury With Otolaryngologic Concordance Background Tracheostomy decannulation in patients with acquired brain injury (ABI) requires assessment of airway protection, secretion clearance, and laryngeal function. Clinical decision-making often relies on invasive airway evaluation such as nasopharyngolaryngoscopy (NPL). However, these procedures may not be readily available in neurorehabilitation settings, particularly in resource-limited environments. This dataset supports a prospective observational cohort study evaluating the diagnostic accuracy of a structured non-invasive bedside decannulation protocol incorporating clinical assessment and laryngeal ultrasonography. The protocol was validated against blinded otolaryngologic assessment using NPL as the reference standard. Objective To evaluate the diagnostic performance and clinical concordance of a structured bedside protocol for determining readiness for tracheostomy decannulation in adults with acquired brain injury undergoing neurorehabilitation. Study Design Prospective observational cohort study. Study Setting A tertiary neurorehabilitation centre in South India. Study Period July 2021 – March 2025. Participants Adults with acquired brain injury (ABI) with a tracheostomy admitted for neurorehabilitation. Inclusion Criteria Age 18–65 years Diagnosis of acquired brain injury (traumatic brain injury, stroke, hypoxic–ischemic encephalopathy, or related neurological injury) Tracheostomy duration >21 days Glasgow Coma Scale ≥10T Oxygen saturation ≥94% on room air Exclusion Criteria Ongoing ventilator dependence Active respiratory infection History of laryngeal trauma or previous laryngeal surgery Sample Size 36 participants. Bedside Decannulation Protocol The dataset includes results of a four-parameter bedside decannulation protocol, evaluating three physiological domains: pulmonary competence, airway protection, and laryngeal patency. Protocol Components Tracheostomy capping tolerance Continuous capping ≥48 hours without respiratory distress. Secretion burden ≤2 tracheal suction episodes per 24 hours. Modified Evans Blue Dye Test Screening for aspiration. Laryngeal ultrasonography Assessment of vocal cord mobility using high-frequency linear ultrasound. Participants were classified as protocol positive (eligible) or protocol negative (not eligible) for decannulation based on these criteria. Reference Standard All participants underwent flexible nasopharyngolaryngoscopy (NPL) performed by otolaryngologists blinded to bedside protocol results. NPL evaluated: Vocal cord mobility Swallowing safety using the Penetration–Aspiration Scale (PAS) Decannulation was considered contraindicated if: Vocal cord mobility was significantly reduced, or Aspiration severity was PAS ≥6. Outcomes Primary Outcomes Diagnostic accuracy of the bedside protocol compared with NPL findings Successful tracheostomy decannulation Agreement between protocol and NPL findings (Cohen’s κ) Secondary Outcomes Diagnostic performance of individual protocol components Clinical complications during 4-week follow-up (aspiration pneumonia or recannulation) Dataset Description The dataset contains de-identified participant-level data including: Demographic variables Etiology of brain injury Tracheostomy duration Bedside protocol parameters Protocol classification (positive/negative) NPL findings Decannulation outcome Diagnostic accuracy metrics Key Results Among 36 participants: Protocol positive: 26 Protocol negative: 10 Diagnostic performance of the composite bedside protocol: Sensitivity: 96.0% Specificity: 81.8% Positive predictive value: 92.3% Negative predictive value: 90.0% Diagnostic accuracy: 91.7% Cohen’s κ agreement: 0.80 No cases of aspiration pneumonia, respiratory deterioration, or recannulation were observed during the four-week follow-up period. Data Availability The dataset is de-identified and shared for research and reproducibility purposes. Individual participant identifiers have been removed to protect confidentiality. Ethical Approval Ethical approval was obtained from the Institutional Review Board of Christian Medical College, Vellore (IRB Minute No. 13989; June 2, 2021). License Recommended license: Creative Commons Attribution 4.0 (CC-BY 4.0).