Respiratory Muscle Function, Dyspnea, Exercise Capacity and Quality of Life in Severe COVID19 Patients After ICU Discharge: a 6 Months Follow-up Observational Study
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
- Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
研究概览
简要总结
Further knowledge regarding sequelae in severe COVID-19 patients who have required ICU admission for invasive mechanical ventilation is still needed. Available evidence suggests ongoing respiratory impairment and impact in quality of life.
详细描述
PURPOSE: To evaluate post-ICU clinical outcomes in severe COVID-19 ICU survivors.
DESIGN: A prospective observational study conducted in public hospital in Madrid, Spain.
METHODS:
Participants: patients diagnosed with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation and have been discharged from hospital.
Intervention: Patients will be invited to attend follow-up visits at the hospital for assessments 3 months and 6 months after ICU discharge.
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,
- •subjects diagnosed with COVID-19 confirmed by positive SARS-CoV-2 PCR testing who require admission to ICU for invasive mechanical ventilation
- •invasive ventilation > 24 hours.
排除标准
- •pre-existing cognitive impairment,
- •communication/language barrier
- •any concurrent physical or mental health condition/ impairment that prevents subjects from taking part in evaluations or providing informed consent
- •loss of independent walking ability (with or without walking aids) prior to hospitalisation defined by a score of ≤2 on the mobility item of the modified Barthel Index,
- •pregnancy,
- •any injuries/surgery that requires medical bed rest.
结局指标
主要结局
Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)
时间窗: within 6 months after ICU discharge
It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.
次要结局
- Diaphragm Thickening Ratio during quiet breathing (centimetres)(within 6 months after ICU discharge)
- Saint George's Respiratory Questionnaire (SGRQ) score(within 6 months following ICU dischargemonths following ICU discharge)
- Diaphragm Thickening Ratio during deep breathing (centimetres)(within 6 months after ICU discharge)
- Modified Medical Research Council (mMRC) Dyspnea score(within 6 months following ICU discharge)
- Maximal Expiratory Pressure (MEP) (cmH20)(within 6 months after ICU discharge)
- 6-Minutes Walk Test (6MWT) (metres)(within 6 months following ICU discharge)
- Diaphragm Excursion during deep breathing (centimetres)(within 6 months after ICU discharge)
研究者
Maria Natividad Seisdedos Nunez
Senior Physiotherapist, MSc
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal