Correlation Between Muscle Strength and Thickness in Critically Ill Patients: an Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between quadriceps strength and thickness
研究概览
简要总结
Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.
The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.
The primary inquiries this study seeks to address are:
- Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?
- How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV?
详细描述
The methodology for measuring the thickness of the diaphragm and quadriceps involves the use of bedside ultrasound. In terms of diaphragmatic assessment, to ensure consistency over multiple timepoints, the areas of the lower limbs evaluated (Quadriceps thickness, Qthick and Cross section area, CSA) will be marked on the skin using a dermatographic pen during the peripheral assessments.
Muscle strength in the limbs will be assessed utilizing the Medical Research Council (MRC) Score, specifically in patients who are awake and cooperative (RASS 0 +/- 1). Additionally, a dynamometer will be employed for the precise measurement of quadriceps strength, serving as the gold standard.
The timeline for data collection during the observational period is structured as follows:
T1: 48-72 hours from the start of invasive MV after intubation T2: At the initial trial in pressure support mode. T3: Immediately prior to extubation. T4: Before discharge from the Intensive Care Unit.
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
- •Age ≥ 18 years;
- •Intubated patients on mechanical ventilation presumably for 48 hours;
- •Informed consent
排除标准
- •Contraindication (absolute or relative) to assessment: acute bleeding, multiple fractures or trauma, spinal instability;
- •Hemodynamic instability during assessment;
- •ICU admission due to thoracic surgery, including lung transplant patients;
- •History of preexisting neuromuscular diseases;
- •History of preexisting functional impairment;
- •Pheripheral Neural disease;
- •Cervical spine injury;
结局指标
主要结局
Correlation between quadriceps strength and thickness
时间窗: The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months)
Degree of correlation between quadriceps strength, measured via handheld dynamometer (strength in Newton), and thickness, measured using ultrasound (thickness in cm).
次要结局
- Quadriceps strength(The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months))
- Diaphragm thickness(The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months))
- Diaphragm strength(The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months))
- Time to reach the sitting position(The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months))
- Quadriceps thickness(The assessment will be perform at 48-72 hours from start of invasive MV after intubation, at the initial trail in pressure support mode, at immediately prior to extubation and at discharge from the Intensive Care Unit (assessed up to 5 months))
研究者
Veronica Rossi
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico