Preoperative Self-assessment for Cardio-pulmonary Risk Stratification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Postoperative pulmonary complications (PPC)
研究概览
简要总结
This prospective study intends to development and validation a patient self-assessment questionnaire. The aim of the self-assessment, by questionnaire, is to estimate the risk of postoperative pulmonary complications (PPC).
详细描述
PPC are common adverse events operative patients. Existing concepts of pulmonary risk evaluation are based on complex risk scores, preoperative apparatus examinations, laboratory parameters and medical findings. The significance of apparatus diagnostics for the preoperative Pulmonary risk evaluation is highly controversial and guidelines recommend a reluctant use. A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic risk assessment. In a large study it could be shown that a subjective self-assessment of physical performance by means of a structured questionnaire (DASI), in contrast to a subjective medical assessment, suitable for predicting perioperative cardiac events. Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.
Objectives:
- Development of a self-assessment questionnaire as part of a Delphi trial
- Validation of the self-assessment questionnaire
Methodology:
Prospective observational, case control study of 5000 patients undergoing surgery in general anesthesia (estimated enrollment of 5500 patients with a dropout rate of approximately 10%).
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
- •18 years and older
- •Operations in general anesthesia
排除标准
- •< 18 Years
- •Pregnancy
- •Lack of cooperation
结局指标
主要结局
Postoperative pulmonary complications (PPC)
时间窗: until hospital discharge up to 6 months after surgery
European Perioperative Clinical Outcome (EPCO) definitions
次要结局
- Major Adverse Cardiac Events (MACE)(until hospital discharge up to 6 months after surgery)
- Duration of hospitalization (days)(until hospital discharge up to 6 months after surgery)
- in-hospital mortality(until hospital discharge up to 6 months after surgery)
- New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses(until hospital discharge up to 6 months after surgery)
- Length of stay in the intensive care unit (days)(until hospital discharge up to 6 months after surgery)
研究者
André Dankert, MD
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
