Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Adverse Hospital Discharge Disposition
研究概览
简要总结
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).
详细描述
Our research group aims to better understand how patients on the SICU are mobilized and the impact it has on adverse discharge disposition and functional outcome after hospital discharge.
We have previously developed and validated the Surgical Intensive Care Unit Optimal Mobilization Score (SOMS), an algorithm to guide and facilitate early mobilization to advance mobility of SICU patients (NCT01363102). In addition, we have established the use of bedside ultrasound technology to quantify cross sectional area of the rectus femoris muscle, which allows an objective, user-independent quantification of muscle wasting (NCT02270502).
In this study we measure the dose of mobility, defined as a function of both the mobility provided by nursing and physical therapists (e.g., sitting at the edge of the bed, ambulating) as well as its duration. We will build on an existing mobility intensity quantification tool (NCT01674608) and add a domain that quantifies its duration in order to obtain a broad picture of the mobilization of patients on the SICU. The mobility dose is expressed by the mobility quantification score that has been developed by our team. We will then test the hypotheses that mobilization dose in the ICU predicts discharge disposition, defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility; or in-hospital mortality. Further we will evaluate the association between mobility dose and cross sectional area of the rectus femoris muscle measured by bedside ultrasound as a potential reflection of ICU-acquired muscle weakness (exploratory outcome).
Mobilization Quantification score: MQS (Detailed table linked in reference section)
This score integrates the highest rated activities within each mobility session - from physical therapy and nursing. By multiplying the scale it gets greater and allows a better interpretation of mobility intensity. It adds value of mobility dose across sessions considering the entire spectrum of active participation of the patient over the day.
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
- •Adults (18 years of age or greater)
- •Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
- •Expected stay on the ICU of >=3 days
排除标准
- •Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
- •Hospitalization 1 month prior to ICU admission >7 days
- •Discussion about changing the goals of care from cure to comfort
- •High risk of persistent brain injury (GCS<5 motor component and presence of TBI)
- •Patients with neurodegenerative diseases
- •Subjects with absence of a lower extremity
- •Patients with paraplegia or tetraplegia
- •Pregnancy
结局指标
主要结局
Adverse Hospital Discharge Disposition
时间窗: Patient will be followed until hospital discharge, an expected 3 to 30 days
Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.
次要结局
- 3-Month Mortality(Evaluated three months after hospital discharge)
- Falls(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Rectus Femoris Muscle Cross Sectional Area(Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days.)
- SICU Delirium-free days(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Physical Work Capacity(Measured three months after hospital discharge)
- Mobility Dose as measured by the Mobilization Quantification Score (MQS)(Patients will be followed until SICU discharge, an expected 3 to 30 days.)
- SICU length of stay(Patients will be followed until SICU discharge, an expected 3 to 30 days.)
- SICU Ventilator-free days(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge(Patients will be followed until hospital discharge an expected 3 to 40 days.)
- Hospital length of stay(Patients will be followed until hospital discharge an expected 3 to 40 days.)
- SICU Vasopressor-free days(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- SICU Neuromuscular Blocking drug-free days(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Opioid Use(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Corticosteroid Days(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
- Side effects of mobilization therapy(Patients will be followed until ICU discharge, an expected 3 to 30 days.)
研究者
Matthias Eikermann, MD PhD
Associate Professor of Anaesthesia, Harvard Medical School; Clinical Director, Critical Care Division
Massachusetts General Hospital