NCT04584658已完成不适用
Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
研究概览
简要总结
This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with a positive SARS CoV-2 test.
- •Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.
- •Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.
- •Adult patients aged 18 years - 85 years.
- •Patients that meet threshold for referral to the joint MDT clinic following screening
排除标准
- •Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
- •Patients who are being managed with palliative intent.
- •Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).
结局指标
主要结局
Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
时间窗: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Based on therapy outcome measures from FEES, VoiS
次要结局
- The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)(t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)
- Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation(t = day 0 and 9 months)
- The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.(t = day 5, day 10, day 14, day 21 - For in-patients only.)
- Relationship between severity of dysphonia and/or dysphagia with grade of ARDS(t = day 0 and 9 months)
- Relationship between severity of dysphonia and/or dysphagia with length of intubation(t = day 0 and 9 months)
- Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.(t = day 0, 1 month and 9 months.)
- Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months(t = day 0, 1 month and 9 months)
研究者
Ekpemi Irune
Consultant Otolaryngology, Head & Neck Surgeon.
Cambridge University Hospitals NHS Foundation Trust
研究点 (1)
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