Substudy of Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength.
Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU.
Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Endotracheally intubated
- •Expected time on ventilator > 24 hours
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Severe head trauma where therapeutic coma is indicated
- •Therapeutic hypothermia where therapeutic coma is indicated
- •Status epilepticus where therapeutic coma is indicated
- •Patient has participated in the study before
- •Patient is transferred from another ICU with length of stay > 48 hours
- •Patient is comatose at admission
- •PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
研究组 & 干预措施
Non-sedation
The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive.
Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol.
干预措施: Non-sedation (Other)
Sedation with daily wake-up
The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:
- Open the eyes to verbal commands.
- Follow the examiner's instructions with the eyes.
- Squeeze hands on request.
- Stick out the tongue on request.
After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4.
干预措施: Sedation, control (Other)
结局指标
主要结局
Physical function
时间窗: 3 months after ICU-discharge
Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index. Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025.
次要结局
- Handgrip(3 months after ICU-discharge)
- Thigh muscle size(3 months after ICU-discharge)
- Biomechanical data(3 months after ICU-discharge)
- 6 minute walk(3 months after ICU-discharge)
研究者
Palle Toft
Professor
Odense University Hospital