Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,079
- 试验地点
- 1
- 主要终点
- Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
研究概览
简要总结
Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.
详细描述
Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.
The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.
The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
时间窗: 3 months after the ICU admission
Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3.
次要结局
- Intensity of pain, and risk factors associated with pain at 3 months after ICU admission(ICU discharge (median 7 days))
- Type of pain (ie neuropathic)(ICU discharge (median 7 days) and at 3 months after admission)
- Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)(Median 7 days)
- Pain management and risk factors in the ICU (Type surgery and invasive procedures during ICU: Neurosurgery, orthopedic surgery spine surgery, abdominal surgery, thoracic surgery, thoracic drain)(Median 7 days)
- Demographic data(Baseline)
- General ICU data (Length of invasive mechanical ventilation)(ICU discharge (median 7 days))
- Pain management and risk factors in the ICU (Use of Remifentanyl)(Median 7 days)
- Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))(Median 7 days)
- General ICU data(ICU discharge (median 7 days))
- Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)(Median 7 days)
- Pain management and risk factors in the ICU (Use of locoregional anesthesia)(Median 7 days)
- Pain management and risk factors in the ICU(Median 7 days)
- General ICU data ( Use of prone positionning during invasive mechanical ventilation)(ICU discharge (median 7 days))