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临床试验/NCT04156594
NCT04156594已完成不适用

Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 5,500 人开始时间: 2019年11月4日最近更新:
适应症

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

André Dankert, MD

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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