Early Mobilisation and Relational Touch Practice on Intubated Patients of Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of patients' anxiety
研究概览
简要总结
41.3% of patients hospitalized in intensive care express feeling anxiety when they are systematically questioned. Ventilatory weaning is one of the moments of anxiety for the patient. While being conscious he must tolerate invasive ventilation. The early mobilization of patients in intensive care must be started early, within 24-48 hours, after the patient wakes up. Early mobilization is part of the weaning process from invasive mechanical ventilation in intensive care. It is recommended to reduce it to use relaxation therapies. Several studies have assessed the impact of relational touch in conscious or unconscious patients in intensive care. The SRLF consensus conference in 2010 recommends the use of massage for anxiolytic purposes.
This study aims to assess the impact of relational touch versus standard care on anxiety during the first bedside session, in intubated intensive care patients ventilated for at least 48 hours and presenting with RASS (Richmond agitation sedation scale). ) from 0 to -1.
The study will aussi assess the impact of relational touch versus standard care on the following patient parameters:
- Evaluation of caregiver anxiety with the Spielberger inventory before and after the session
- Increasing the duration of the bedside session;
- Variations in pain, assessed by the Behavioral Pain Scale (BPS) at the end of the session;
- The level of agitation/vigilance at the beginning and at the end of the session with the Richmond agitation-sedation scale (RASS);
- Induced variations in blood pressure;
- Induced variations in oxygen saturation;
- The variations induced on the respiratory rate;
- The variations induced on the heart rate;
- The need to prescribe psychotropic drugs on the day of the first bedside;
- Reduction in the number of days of invasive mechanical ventilation between the first bedside session and discharge from intensive care unit (maximum D28 after the first bedside session).
This is a national, multicenter, cluster, randomized, controlled trial with 4-stage stepped-wedge design (1:1:1:1 randomization), phase III, superiority, open-label, comparing systematic practice relational touch by the paramedical team during bedside sessions, versus standard care (without relational touch).
The benefit is above all for the patient with a better experience of bedside sessions and a reduction in ventilation time, therefore bed rest, leading to a reduction in decubitus complications. The expected economic benefit involves the reduction of decubitus complications and therefore their cost and the reduction of hospitalization times in intensive care.
详细描述
Patient hospitalized in intensive care unit and under invasive mechanical ventilation are recruited in this research. Survivors of critical illness who are hospitalized in intensive care and have been intubated and sedated, experience a lot of problems that begin in the intensive care unit (ICU) and can continue after discharge from intensive care or even hospital.
When questioned, 41.3% of patients hospitalized in intensive care express having felt anxiety. Life in intensive care is a source of numerous, repetitive and frequent psychic traumas whose affective disorders (anxiety, stress, despair) are insufficiently detected. Barriers to better living exist in intensive care; they can be responsible for psychological manifestations such as anxiety.
One of the most distressing psychological experiences for patients receiving mechanical ventilatory support would be anxiety, defined as a state characterized by apprehension, agitation, increased motor tension, autonomic arousal and restlessness. fearful withdrawal.
Prolonged bed rest also has repercussions on the psyche of the patient who is easily anxious, confused and depressed. This prolongs the length of hospital stay. Anxiety is a feeling of dread, fear of lack of control which can manifest as agitation and fearful withdrawal, a reaction to perceived danger; also, a manifestation that can affect the psyche and physiological stability.
According to Nelson et al, between 55 and 75% of patients hospitalized in intensive care report an experience of pain, discomfort or anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Adult patient ventilated invasively for at least 48 hours, RASS between 0 and -1 with early mobilization prescribed but not performed.
排除标准
- •Patient needing help from another person to mobilizing
- •Patient with an unstable fracture
- •Patient with a recent laparotomy (less than 10 days)
- •Patient under judicial protection measures
- •Patient on catecholamines
- •Pregnant or breastfeeding woman
- •Non-communicating patient due to neuropsychiatric pathology
- •Patient benefiting from a process of palliative care or moribund patient whose estimated life expectancy is less than 30 days
- •Strict bed rest order
- •Fraction inspired oxygen (FIO2) >50%
- •Body mass index > 40 Kg/m2
- •Patient having an epidural with motor impairment.
结局指标
主要结局
Evaluation of patients' anxiety
时间窗: at baseline
With the Face Anxiety Scale, anxiety lever of patients will be assessed.
次要结局
未报告次要终点