Substudy of the NONSEDA-trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Posttraumatic Stress Disorder
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
- 2
- 主要终点
- PTSD
研究概览
简要总结
Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.
Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.
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
- Single (Investigator)
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
- •Patient does not speak Danish, swedish or norwegian at a reasonable level
研究组 & 干预措施
Non-sedation
Non-sedation supplemented with pain management during mechanical ventilation.
干预措施: Non-sedation (Other)
Sedation
Current gold standard: Sedation with a daily wake-up trial.
干预措施: Control, sedation (propofol, midazolam) (Other)
结局指标
主要结局
PTSD
时间窗: 3 months after discharge from ICU
Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria.
次要结局
- Anxiety(3 months after discarge from ICU)
- Patient-reported quality of life(3 months after discharge from ICU)
- Depression(3 months after discharge from ICU)
研究者
Palle Toft
Professor
Odense University Hospital