Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Number of days between hemodynamic stability and ICU discharge
研究概览
简要总结
Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated.
The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock
The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on:
- the duration between hemodynamic stability* and the removal of sedation
- the duration between the removal of sedation and ICU discharge
- the mechanical ventilation duration (invasive and noninvasive)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 ICU
- •Septic shock diagnosed more than 24 hours before inclusion
- •Patient hemodynamically stable, before the 72th hour following the diagnosis of septic shock
- •Mechanical ventilation by tracheal intubation
- •Patient sedated with a RASS score inferior or equal to -2
- •Age ≥ 18 years
- •BMI ≤ 40 kg / m²
- •Informed patient having signed the consent
- •Effective contraception in women of childbearing age (pregnancy test by B-HCG will be done; for menopausal women, a diagnosis of confirmation must be obtained).
排除标准
- •BMI> 40kg / m²
- •Patient reduced by one or two lower limbs
- •Rheumatological pathology, trauma or surgery of the lower limbs, pelvis or spine resulting of any limitations of the range of motions or strict immobilization
- •Brain-injured patient and / or medulla injured
- •Hemodialysis continues with a femoral catheter without possibility of changing the catheter location
- •Moribund patient, Stop or Limitation of Active Therapeutics' decision
- •Contraindications to standard physical therapy or the cyclo-ergometer
- •Untreated orthopedics: deep vein thrombosis of the member concerned
- •Dermatological: severe lesions or complex dressings in the sector concerned
- •Patient with ExtraCorporeal Membrane Oxygenation (ECMO)
- •Pregnant or breastfeeding women
- •Patient participating in another trial with the same main objective
结局指标
主要结局
Number of days between hemodynamic stability and ICU discharge
时间窗: approximately 1 month
Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and ICU discharge
次要结局
- Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU(From 3 to 10 days)
- Number of days between hemodynamic stability and the removal of sedation(From 3 to 10 days)