Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- End Acceleration Measured in Tibialis Anterior
研究概览
简要总结
The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.
详细描述
The primary purpose of this study is to develop a procedure to identify intensive care unit (ICU) acquired weakness. This condition occurs in a subset of people admitted into the ICU, and is associated with a 30% increased risk of death before discharge from the ICU. There are currently major limitations in the ability to diagnose ICU acquired weakness, making it difficult to study. The goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. The current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. This study is designed to test out the procedures in patients who have been transferred from the ICU to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients transferred from the ICU to a lower level of care within the past 7 days
- •Mechanical ventilation for greater than 7 days while in the ICU
- •Ability to understand English and provide written consent
排除标准
- •Vulnerable populations including: patients who are pregnant or prisoners
- •Patients who are unable to understand English or provide written consent
结局指标
主要结局
End Acceleration Measured in Tibialis Anterior
时间窗: Day 1
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
时间窗: Day 1
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.
End Acceleration Measured in Extensor Carpi Radialis Longus
时间窗: Day 1
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Peak Acceleration Measured in Extensor Carpi Radialis Longus
时间窗: Day 1
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Peak Acceleration Measured in Tibialis Anterior
时间窗: Day 1
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
时间窗: Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz
The time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Time to Peak Acceleration Measured in Tibialis Anterior
时间窗: Day 1
The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Fatigue Ratio Measured in Tibialis Anterior
时间窗: Day 1
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.
次要结局
未报告次要终点
研究者
Randi Smith
Assistant Professor
Emory University