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).# 数据集：伴耳鼻咽喉科一致性验证的获得性脑损伤（acquired brain injury, ABI）患者无创床边气管切开拔管方案的前瞻性验证研究 ## 背景 获得性脑损伤（ABI）患者的气管切开拔管需评估气道保护能力、分泌物清除能力及喉功能。临床决策通常依赖有创气道评估手段，如经鼻咽喉镜（nasopharyngolaryngoscopy, NPL）。但此类操作在神经康复病房，尤其是资源有限的医疗环境中往往难以开展。 本数据集支撑一项前瞻性观察队列研究，旨在评估整合临床评估与喉部超声检查的标准化无创床边拔管方案的诊断效能。该方案以经鼻咽喉镜（NPL）为参考标准，通过盲法耳鼻咽喉科评估对其进行验证。 ## 研究目的 评估针对接受神经康复治疗的获得性脑损伤成年患者，标准化床边拔管方案用于判断气管切开拔管适配性的诊断性能与临床一致性。 ## 研究设计 前瞻性观察队列研究。 ## 研究场景 印度南部一家三级神经康复中心。 ## 研究周期 2021年7月—2025年3月。 ## 研究对象 因神经康复入院、伴气管切开的获得性脑损伤成年患者。 ## 纳入标准 1. 年龄18~65岁； 2. 确诊获得性脑损伤（包括创伤性脑损伤、脑卒中、缺氧缺血性脑病或相关神经系统损伤）； 3. 气管切开置管时长＞21天； 4. 格拉斯哥昏迷量表（Glasgow Coma Scale）评分≥10T； 5. 室内空气下血氧饱和度≥94%。 ## 排除标准 1. 持续依赖呼吸机； 2. 活动性呼吸道感染； 3. 喉外伤史或既往喉部手术史。 ## 样本量 共36名研究对象。 ## 床边拔管方案 本数据集包含四项参数的床边拔管方案评估结果，覆盖三大生理领域：肺功能状态、气道保护能力及喉腔通畅性。 ### 方案组成要素 1. 气管切开套管封堵耐受性：持续封堵≥48小时且无呼吸窘迫表现。 2. 分泌物负荷：24小时内气管吸痰次数≤2次。 3. 改良伊文思蓝染料试验：用于筛查误吸。 4. 喉部超声检查：采用高频线阵超声评估声带活动度。 研究对象根据上述标准被划分为拔管方案阳性（适配拔管）或阴性（不适配拔管）两类。 ## 参考标准 所有研究对象均接受由耳鼻咽喉科医师实施的盲法经鼻咽喉镜（NPL）检查，且医师对床边拔管方案的评估结果不知情。NPL评估内容包括：声带活动度；采用渗透-误吸量表（Penetration–Aspiration Scale, PAS）评估吞咽安全性。 若出现以下任一情况，则判定气管切开拔管为禁忌： 1. 声带活动度显著降低； 2. 误吸严重程度达到PAS≥6级。 ## 研究结局 ### 主要结局 1. 床边拔管方案与NPL检查结果对比的诊断准确性； 2. 气管切开拔管成功率； 3. 拔管方案与NPL检查结果的一致性（科恩κ值，Cohen’s κ）。 ### 次要结局 1. 各方案组成要素的诊断性能； 2. 4周随访期内的临床并发症（误吸性肺炎或再次气管切开）。 ## 数据集说明 本数据集包含去标识化的受试者个体水平数据，具体包括：人口统计学变量、脑损伤病因、气管切开置管时长、床边拔管方案参数、方案分类结果（阳性/阴性）、NPL检查结果、拔管结局、诊断准确性指标。 ## 关键结果 共纳入36名研究对象：其中方案阳性26例，方案阴性10例。 复合式床边拔管方案的诊断性能如下： - 灵敏度：96.0% - 特异度：81.8% - 阳性预测值：92.3% - 阴性预测值：90.0% - 诊断准确率：91.7% - 科恩κ一致性系数：0.80 4周随访期内未观察到误吸性肺炎、呼吸恶化或再次气管切开病例。 ## 数据可用性 本数据集已完成去标识化处理，仅用于科研与可重复性研究目的。已移除所有受试者个体识别信息以保护隐私。 ## 伦理审批 本研究已通过韦洛尔基督教医学院伦理审查委员会审批（伦理委员会会议纪要编号：13989；2021年6月2日）。 ## 许可协议 推荐使用许可协议：知识共享署名4.0（Creative Commons Attribution 4.0, CC-BY 4.0）。