Post-extubation Assessment of Laryngeal Symptoms and Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Laryngeal injury as assessed by 4-point categorical scale
研究概览
简要总结
The goal of this study is to learn more about voice and airway problems that patients experience during and after the time patients have an oral endotracheal tube in patients' airway to help patients breathe while receiving mechanical ventilation in an intensive care unit (ICU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Required mechanical ventilation via an oral endotracheal tube
- •Anticipated intubation ≥8 hours
排除标准
- •Pre-existing dysphonia, dysphagia
- •Pre-existing central nervous system, neuromuscular, or connective tissue disease
- •Prior tracheotomy and/or tracheotomy placed prior to enrollment
- •History of major thoracic surgery (e.g., sternotomy, thoracotomy) prior to the current admission
- •Head and/or neck disease
- •Head and/or neck surgery other than tonsillectomy
- •Known or suspected anatomical abnormalities or pre-intubation trauma of the oral cavity, pharynx, larynx, or esophagus
- •Unlikely to be extubated (i.e., expected death)
结局指标
主要结局
Laryngeal injury as assessed by 4-point categorical scale
时间窗: Within 72 hours post-extubation
Characterize injuries to the larynx and surrounding tissues/anatomy after mechanical ventilation is no longer required and the oral endotracheal tube is removed. Injuries will be graded on a 4-point categorical scale ranging from 0 (no injury) to 3 (severe injury).
Laryngeal injury symptom grading by Laryngeal Hypersensitivity Questionnaire (LHQ)
时间窗: Within 48 hours of anticipated extubation
Characterize patient symptoms of laryngeal injury within 48 hours of anticipated extubation. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time).
Laryngeal injury symptom grading by LHQ
时间窗: 7 days post-extubation or hospital discharge, whichever occurs first
Characterize patient symptoms of laryngeal injury at 7 days post-extubation or at discharge whichever comes first. Symptoms will be assessed using a 4-point ordinal scale based on the LHQ, ranging from 1 (all of the time) to 4 (none of the time).
次要结局
- Perceptual voice characteristics as assessed by Grade Rough Breathy Asthenic Strained (GRBAS) method(Within 72 hours post-extubation)
- Perceptual voice characteristics as assessed by GRBAS method(7 days post-extubation or hospital discharge, whichever occurs first)
- Isometric Hand Grip Strength-Dynamometry(Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first)
- Yale Swallow Protocol(Within 72 hours post-extubation)
- Oral endotracheal tube size(At the time of intubation (directly following study enrollment))
- Duration of orotracheal intubation(From date of intubation to date of extubation or placement of a tracheostomy tube, whichever occurs first, assessed up to 14 days)
- Patient perception of voice and voice symptoms assessed by the Voice Symptom Scale (VoiSS)(Within 72 hours post-extubation and at 7 days post-extubation or hospital discharge, whichever occurs first)
- Function Oral Intake Scale (FOIS)(Within 90 days of extubation or at ICU discharge, whichever occurs first)
- Acoustic voice measurement as assessed by voice analysis software(7 days post-extubation or hospital discharge, whichever occurs first)
- Peak tongue strength assessed using the Iowa Oral Performance Instrument (IOPI)(Within 48 hours of anticipated extubation, within 72 hours post-extubation, and at 7 days post-extubation or hospital discharge, whichever occurs first)