The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Cognitive function
研究概览
简要总结
This prospective observational cohort study will investigate the impact of a bundle of nine preventive measures (Assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and ICU Diary) on the incidence and severity of Post-Intensive Care Syndrome (PICS) and clinical outcomes in critically ill patients
详细描述
This is a prospective observational cohort study. It will include all adult patients, admitted to a surgical ICU (13 beds) and a medical ICU (10 beds), with a length of ICU stay of at least 2 day, from January 01 to December 31 2018. Patients with severe cognitive deficits prior to admission, identified by clinical history obtained by the psychology or through the Mental State Mini Exam (MMSE), traumatic brain injury and stroke patients with Glasgow coma scale <14, will be excluded. On admission to the ICU, risk factors for PICS will be identified.
During ICU stay, the patients will be submitted to nine interventions aiming at the prevention of PICS: Assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and ICU Diary. At ICU discharge, the physical, psychiatric and cognitive components of PICS will be evaluated using the following tools: FSS-ICU, dynamometry and nutritional indicators (physical component), HADS (Anxiety and Depression), MOCA (cognitive dysfunction) and PCL -C (posttraumatic stress disorder). The duration of mechanical ventilation, duration of sedation, ICU LOS and hospital mortality will also be evaluated. Reassessments will be done 5 days after discharge from the ICU or at hospital discharge (what happens first) and 3 months after the randomization at the follow-up clinic. Patients identified with PICS at discharge from the ICU will be compared with those who did not develop the syndrome. The investigators will specifically evaluate the percentage of adherence to preventive measures, the presence of risk factors and clinical outcomes.
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
- •Adult non pregnant patients
- •Length of ICU stay of at least 2 days.
排除标准
- •Severe cognitive deficits prior to admission.
- •Traumatic brain injury with Glasgow coma scale < 14
- •Stroke with Glasgow coma scale < 14
结局指标
主要结局
Change in Cognitive function
时间窗: Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool,
Change in Psychiatric function
时间窗: Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Evaluation of psychiatric dysfunction using the HADS (Hospital Anxiety and Depression Scale).
Change in physical function
时间窗: Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Evaluation of physical dysfunction through FSS-ICU (Functional status score in the ICU)
Change in Post-traumatic stress syndrome
时间窗: Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic
Identification of post-traumatic stress syndrome through PCL-C (Post-traumatic stress checklist-civilian)
次要结局
- The duration of mechanical ventilation,(During ICU stay.. Expected average 21 days)
- ICU LOS(During ICU stay. Up to 30 days)
- Physical function(ICU discharge (baseline) and change from baseline at 3 months)
- Duration of sedation(During ICU stay. Expected average 21 days)
- Hospital Mortality(90 days)
研究者
José Raimundo Araujo de Azevedo
Director of ICU
Hospital Sao Domingos