Effect of the "Sitting Out of Bed in an Arm-chair Position" in ICU on Functional Recovery Among Ventilated Patients: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- Functional level on "discharge" from intensive care
研究概览
简要总结
Chair positioning is one of a series of early mobilization techniques. At present, this technique, which involves moving a patient out of the resuscitation bed, can be performed passively or actively. It does not constitute a rehabilitative act as such, but it is considered in common paradigms as a technique to improve "the patient's breathing and strength".
However, recommendations issued in 2013 by the Society of intensive care physiotherapy and the society "Société de réanimation de langue française (SRLF)", reveal that this chair position cannot be recommended with a high grade.
The aim of the investigators is therefore to break down this early mobilization process in intensive care, to find out whether the armchair is an indispensable tool for improving functional and muscular processes.
The research hypothesis is therefore as follows:
"Early armchairing of the resuscitation patient, improves functional recovery compared to a conservative positioning strategy (sitting in bed)."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 > 18 years old
- •Patient on invasive mechanical ventilation for more than 24 hours
- •Patient in recovery phase with a RASS score greater than "-3" for more than 12 hours
- •Stay expected to last 48 hours
- •Patient has never been placed in a chair during this hospitalization in intensive care.
- •Fragility score < 6, during the month preceding admission to intensive care
- •Patient (or support person/relative if patient is unable to participate) who has agreed to take part in the study.
排除标准
- •Patient with an absolute and non-resolving contraindication to chair positioning
- •Fracture or orthopedic disorder contraindicating mobilization out of bed
- •Obesity with body mass index greater than 45 kg/cm2
- •Sacral eschar stage greater than 2
- •Patient using a wheelchair for mobility (i.e. paraplegic patient or patient with progressive neurological pathology).
- •Patient treated with veno-venous or veno-arterial ECMO at the time of screening.
- •Moribund patient
- •Encephalic death
- •Acute polyradiculoneuritis (Guillain-Barré syndrome)
- •Patient treated by continuous hemodialysis or hemofiltration for more than 72 hours following the onset of awakening.
- •Complete transmetatarsal or higher amputation of one or both lower limbs.
- •Protected person (under guardianship or curatorship)
- •Person under court protection
- •Person not affiliated to a social security scheme
- •Pregnant or breast-feeding woman
- •Patient already included in the study
- •Patient taking part in an interventional clinical study, the aim of which is to show an improvement in functional level on discharge from the intensive care unit or which focuses on the theme of early rehabilitation in the intensive care unit.
研究组 & 干预措施
No chair position
sitting out of bed in an arm-chair position
干预措施: sitting out of bed in an arm-chair position (Other)
结局指标
主要结局
Functional level on "discharge" from intensive care
时间窗: On discharge from intensive care or day 28 (depending on which comes first)
Functional level at "discharge" from the intensive care unit measured by the Physical Function ICU Test scored (PFIT-s). Minimum value = 0 , meaning worse functionnal status Maximum value = 12, meaning better functionnal status
次要结局
- ICU Mobility scale(Day 28)
- MRC sum score(Day 28)
- Length of stay in intensive care unit(Day 28)
- Ventilator free days(Day 28)
- Mortality rate(Day 28)
- Total length of hospital stay(Day 28)
- Mortality(Month 6)