Assessment of Diaphragmatic Function by Ultrasonographic Measure of Diaphragmatic Thickening in Severe Sepsis or Septic Shock Patients Hospitalized in ICU: Diaphragmatic Dysfunction Frequency, Prognosis Values and Associated Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diaphragmatic Dysfunction with DTF Ultrasound measure
研究概览
简要总结
Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction frequency, its prognosis value and its associated factors.
This is a prospective pilot study in a 14-bed medical and surgical ICU including 50 consecutive patients with severe sepsis or septic shock. The expected duration of study is 18 months.
DTF is measured each day as follow: the probe is placed in an intercostal space between mid axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic sinus. DTF measure is performed in B-mode using the following formula: TF (%) = [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. A DTF < 20% indicates a diaphragmatic dysfunction.
The investigators will collect potential factors for which DTF Ultrasound Measure could have a prognosis value (intubation, successful or failed weaning from mechanical ventilation), potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors.
The investigators expect measure of DTF allows identifying patient with severe sepsis or septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction frequency with ultrasound measure and warranting its use routinely at the bedside. The investigators expect that DTF helps to characterize degree of severity of septic patient and can be a new index able to predict intubation in this population.
详细描述
Rational Severe sepsis and septic shock represent the first cause of death in ICU (42% to 60% mortality rate). Sepsis is defined by alteration of cellular function, immune dysregulation, coagulation and metabolism disorders, following the Systemic Inflammatory Response Syndrome (SIRS).
Among different affected organs, skeletal muscle is highlighted. Proteolysis increasing, proteosynthesis decreasing and mitochondrial dysfunction lead to an overall muscular cells alteration (sarcolemma, sarcoplasmic reticulum and contractile proteins). These mechanisms induce a reduction of skeletal muscle mass and skeletal muscle-specific force generation. Diaphragm could be the first muscle affected during sepsis (1). Sepsis is the primary risk factor for diaphragmatic dysfunction. Diaphragm could be considered as an organ altered by sepsis (2). Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Its assessment becomes an important issue in order to evaluate the patient severity status, to monitor diaphragm recovery and adjust treatment.
One study evaluated diaphragmatic function with Magnetic Phrenic Nerve Stimulation in mechanically ventilated patients (3) and one with Needle Electromyography of diaphragm in patients with prolonged weaning from mechanical ventilation (4). But any study assessed diaphragmatic function with ultrasound measure of Diaphragmatic Thickening Fraction in patients with severe sepsis or septic shock, mechanically ventilated or not.
Ultrasonography is noninvasive, ionization free, feasible rapidly at the bedside and thus can be regularly used in diaphragm assessment (5). The diaphragmatic thickening fraction (DTF) at the zone of apposition (6) allows to assess thickening capacity of diaphragm during inspiration so its contraction capacity. It is an accurate and reproducible outcome measure for diaphragmatic dysfunction assessment. A DTF < 20% indicates a diaphragmatic dysfunction (7).
We hypothesize that acute diaphragmatic abnormalities are present in ICU septic patient and it can be a prognosis factor of patient severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Patient hospitalized in our Medical/Surgical ICU;
- •Severe sepsis of septic shock (2001 International Sepsis Definition Conference);
- •Age > 18 years;
- •Patient consent.
排除标准
- •Preexisting neuromuscular disorders;
- •Recent cardiac or thoracic surgery;
- •Use of neuromuscular blocking agent within the 24h preceding the first diaphragm assessment;
- •Known preexisting diaphragmatic disorders;
- •Cervical spine injury;
- •Refusal to participate.
结局指标
主要结局
Diaphragmatic Dysfunction with DTF Ultrasound measure
时间窗: Participants will be followed for the duration of ICU stay, an expected average of 10 days
Diaphragmatic dysfunction is defined by DTF \< 20%. Frequency of diaphragmatic dysfunction is measured by the ratio of: number of patient with DTF \< 20% during ICU hospitalization on total number of patients included.
次要结局
- Collection of potential risk factors: age, sex, tobacco, alcohol, cirrhosis, diabetes mellitus(At baseline)
- Collection of potentials associated factors: medication (hypnotics, opioids, steroids, catecholamines), mechanical ventilation, presence of a septic shock, severity score (SOFA), ICU and Hospital Length of stay, ICU and Hospital mortality(Participants will be followed for the duration of ICU stay, an expected average of 10 days)
- Change in Diaphragmatic Thickening Fraction with DTF Ultrasound measure(Participants will be followed for the duration of ICU stay, an expected average of 10 days)
- Collection of potential factors for which DTF Ultrasound Measure could have a prognosis value: intubation, successful or failed weaning from mechanical ventilation(Participants will be followed for the duration of ICU stay, an expected average of 10 days)