A Prospective Observational Study of Patients Suffering From Prolonged Critical Illness Treated by Patient Centered Multidisciplinary Teams at a Specialized Unit: Patient Characteristics, Treatment and Follow-up Results
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in mechanical ventilation status
研究概览
简要总结
This prospective observational study aims to describe the outcome for patients with persistent or chronic critical illness treated at Remeo, a clinic specialized for patients in need of prolonged intensive care and intensive care rehabilitation in Sweden. Patients' disease characteristics and the treatment in multidisciplinary patient centered teams for intensive care, weaning from mechanical ventilation and simultaneous rehabilitation will be described. Patients will be followed one year after discharge to document health related quality of life, physical function, frailty, mental illness and used health care resources.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness
排除标准
- •Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)
结局指标
主要结局
Change in mechanical ventilation status
时间窗: Assessed at admittance and immediately after discharge from unit
Time (Days) from admittance to unit until weaned from mechanical ventilation
In-patient mortality and mortality
时间窗: Assessed immediately after discharge from unit
Mortality during care at unit
Mortality during 12 months follow-up after discharge
时间窗: Assessed 12 months after discharge
Mortality during 12 months follow-up after discharge
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
时间窗: 12 months after discharge from unit
RAND36 (scale 0-100, higher value better) questionnaire
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
时间窗: 12 months after discharge from unit
EQ-5D-5L questionnaire
Change in tracheostomy status
时间窗: Assessed at admittance and immediately after discharge from unit
Time (Days) from admittance to unit until decannulation
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
时间窗: 12 months after discharge from unit
Katz ADL (scale 0-6, higher value better)
次要结局
- Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(12 months after discharge from unit)
- Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire(12 months after discharge from unit)
- Swallowing function and possibility of oral intake(At at 12 months after discharge from unit)
- Frailty as assessed by the Clinical frailty scale (CFS)(At 12 months after discharge from unit)
- Physical status as assessed by the 6 minutes walk test(12 months after discharge from unit)
- Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).(12 months after discharge from unit)
- Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test(Immediately before discharge from unit)
- Inflammatory status relative to outcome(Through study completion, an average of 14 months)