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临床试验/NCT04550143
NCT04550143已完成不适用

Diaphragm Dysfunction and Peripheral Muscle Wasting in Septic Shock Patients: Exploring Their Relationship Over Time Using Ultrasound Technology

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Association between SWE assessment and other muscle ultrasound markers.

研究概览

简要总结

Intensive Care Unit (ICU) patients are known to lose muscle mass and function for many reasons, ranging from prolonged immobilization, to the effects of ICU treatments such as mechanical ventilation (MV), to the critical illness itself. Ultrasonography (US) is widely used in the ICU setting and has greatly evolved in the last decades, since it allows the non-invasive assessment of different structures, using radiation-free and user-friendly technology; its application for the assessment or the skeletal muscle is a promising tool and might help detecting muscle changes and thus several dysfunctions during early stages of ICU stay.

By using skeletal muscle ultrasound at both diaphragm and peripheral levels, the overall aim of this study is to improve knowledge in the early detection of muscle dysfunction and weakness , and their relationship with mechanical ventilation weaning and muscle strength, in critically ill patients suffering from septic shock.

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

入选标准

  • adult patients (> 18 years old) admitted to the ICU
  • with a diagnosis of septic shock
  • a SOFA score equal or superior to 8 points, at ICU admission
  • blood lactate concentration above 2 mmol/L, at ICU admission
  • expected to have more than 48h of mechanical ventilation (estimated by the attending physician)
  • expected to stay more than 5 days in the unit (estimated by the attending physician)
  • able to walk prior to ICU admission / walking aids accepted;

排除标准

  • lower limb amputation, fixators or open wounds
  • thoracic fixators or open wounds
  • diagnosed neuromuscular or central nervous system diseases
  • being transferred from another ICU
  • spinal cord injury
  • diaphragm pacemaker
  • palliative goals of care
  • cancers derived sarcopenia
  • anorexic disorders (protein-energy malnutrition)
  • intellectual or cognitive impairments, limiting the ability to follow instructions.

结局指标

主要结局

Association between SWE assessment and other muscle ultrasound markers.

时间窗: ICU discharge, approximately 10 days

To explore the existence of an association between SWE assessment and other muscle ultrasound markers (TDI, TFDI, CSARF and ECHORF) for each muscle (diaphragm and quadriceps rectus femoris muscles) over the ICU stay, in adult patients (\> 18 years old) admitted for a septic shock.

次要结局

  • Association between the rate change (%) in DUS and PMUS assessments.(Time-points of assessment relating to baseline (ICU admission) values.)
  • Weaning success/failure predictive model.(Between ICU admission and extubation moment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Bendjelid

Professor

University Hospital, Geneva

研究点 (1)

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