Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Average achieved SOMS level
研究概览
简要总结
The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables.
详细描述
The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adults (18 years of age or greater)
- •Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours
- •Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission
排除标准
- •Irreversible disorders with 6-month mortality greater than 50%
- •Rapidly developing neuromuscular disease
- •Cardiopulmonary arrest
- •Motor component of Glascow Coma Scale <5
- •Elevated intracranial pressure
- •Ruptured/leaking aortic aneurysm
- •Acute MI before peak troponin has been reached
- •Absent lower limbs
- •Pregnancy
- •Unstable fractures contributing to likely immobility
- •Hospitalization prior to ICU admission >5 days
- •Enrollment in another clinical trial
结局指标
主要结局
Average achieved SOMS level
时间窗: Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks).
Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.
次要结局
- Muscle strength(ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.)
- SICU length of stay(Patients will be followed until SICU discharge, an expected 2 days to 2 weeks)
- The "mini" modified Functional Independence Measure (mmFIM) level(mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.)
- Quality of life following hospital discharge(three months after hospital discharge)
- Side effects of mobilization therapy(during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.)
- Genetic Polymorphisms as related to the other outcomes(5 minutes to collect sample)
研究者
Matthias Eikermann
Director of Research, Surgical Intensive Care Unit
Massachusetts General Hospital