ICU Associated Weakness and Its Association With Tibialis Anterior Cross-sectional Area Changes Assessed by Serial Bedside Ultrasound Assessments
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Correlation of tibialis anterior muscle atrophy development with whole-body strength
研究概览
简要总结
ICU-associated weakness is a common experience for people following a critical illness. It is associated with important patient and system-relevant outcomes. Diagnosing ICU-associated weakness can be challenging because making the diagnosis relies on volitional participation in strength testing by the patient in a very ill population that is often sedated or restrained.
This study proposes to test if bedside ultrasound of tibialis anterior (a non-invasive test that doesn't require active participation by the patient) correlates with clinical whole-body weakness in critically ill patients admitted to an ICU with sepsis.
详细描述
BACKGROUND
Physical weakness is a common during and after critical illness. Weakness can develop for multiple reasons, but it can be generally be grouped into three overlapping categories:
- Nervous system dysfunction - weakness can result from impairments in the nervous system control of muscles;
- Muscle size reductions (i.e. sarcopenia) - muscles become smaller with disuse, and;
- Muscle force reductions (i.e. dynapenia) - muscles develop contractile impairments.
In critical care, diagnostic criteria have been developed for a syndrome of weakness called intensive care unit-acquired weakness (ICU-AW). ICU-AW has important clinical implications. It is associated with delayed ventilator weaning, increased mortality, and longer lengths of stay in the hospital. ICU-AW can also have consequences for patients after they leave the hospital. ICU-AW can be implicated in impairments in quality of life and physical function such as difficulty climbing stairs, and delays in returning to work.
Diagnosing ICU-AW is not trivial and it is centered on assessments targeted primarily to assessing dynapenia. The diagnostic criteria are clear but making the diagnosis relies on the active participation of patients, and the reliable subjective assessment by clinicians at the bedside. Factors such as sedation, restraint use, paralytic medications, pain, and dressings can all confound the assessment of a patient's strength.
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 patients (age > 18 years);
- •admitted to the ICU with a diagnosis of sepsis, and;
- •an ICU duration of stay of greater than 4 days (two allow for serial assessments of muscle strength and size).
排除标准
- •Any pre-existing diagnosis that would reasonably impact a participant's muscle bulk, strength, coordination, or ability to participate in the assessment
- •Critical illness myopathy, critical illness neuropathy, and critical illness polyneuropathy diagnosed in the current ICU stay are not to be considered exclusion criteria as these diagnoses are directly related to the research question
- •Delirium is not considered an exclusion criteria for this study so long as at least two strength assessments can be performed during the course of the participant's ICU stay.
- •Any activity orders or movement restrictions (including medical devices such as casts or external fixation devices) that would preclude accurate motor strength assessment.
- •Dressings, casts, or medical implements that would preclude or impede ultrasound assessment of tibialis anterior muscle cross-sectional area in both legs.
- •Patients who are "proned" or in positions that make assessing tibialis anterior with ultrasound or physical exam impractical.
- •Re-admission to ICU within the same hospital stay.
结局指标
主要结局
Correlation of tibialis anterior muscle atrophy development with whole-body strength
时间窗: First two weeks of ICU admission
Determine if the rates of decline of tibialis anterior muscle cross-sectional area (%/day) measured by bedside ultrasound on participants admitted to an ICU for sepsis correlate with bedside clinical measures of strength using the MRC sum score.
次要结局
- Correlation of tibialis anterior muscle atrophy development with ankle dorsiflexion strength(First two weeks of ICU admission)
- Correlation of tibialis anterior muscle atrophy development with illness severity at admission ICU(First two weeks of ICU admission)
- Correlation of tibialis anterior muscle atrophy development with duration of mechanical ventilation in ICU(First two weeks of ICU admission)
- Correlation of tibialis anterior muscle atrophy development with ICU length of stay(First two weeks of ICU admission)
- Correlation of tibialis anterior muscle atrophy development with hospital length of stay(First two weeks of ICU admission)