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临床试验/NCT05861089
NCT05861089已完成不适用

Rest PETCO2 as a Predictor of Post-operative Complications in Patient Undergoing Major Vascular Surgery

St. Anne's University Hospital Brno, Czech Republic2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
2
主要终点
post-operative complications

研究概览

简要总结

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty and often can not undergo CPET. In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

详细描述

Cardiopulmonary exercise testing (CPET) is considered to be a golden standard in preoperative risk assessment and stratification of high risk patients scheduled for major surgery. However, not all of the patients requiring surgery are willing or able to complete this type of testing. Moreover, inability to perform CPET has been linked with inferior outcomes following surgery.

Vascular surgery patients are predominantly elderly people, with significant comorbidity and high degree of frailty. Therefore, CPET as a mean of risk stratification would be of an especial interest in this group of patients. However, vascular surgery patients often present with peripheral arterial disease, which may contribute to early leg ischemia during exercise and therefore invalid cardiorespiratory reserve function measurement.

In recent years, new parameters with similar prognostic value as standard CPET parameters were studied. Specifically, the partial pressure of end-tidal carbon dioxide (PETCO2) at rest has been shown to have the same prognostic value as ventilatory efficiency in the prediction of post-operative complications in lung resection surgery patients. Whether the same parameter can be used to predict postoperative complications in a different sub-set of surgical patients (i.e. vascular surgery patients) is yet to be determined.

We hypothesized low PETCO2 at rest will be associated with the development of pulmonary and cardiovascular post-operative complications in patients after major vascular surgery. Accordingly, our aim is to compare PETCO2 measured at rest before surgery in patients who develop post-operative complications and in those who do not.

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

  • indication for major vascular surgery (aortobifemoral bypass surgery)

排除标准

  • tracheostomy

研究组 & 干预措施

vascular surgery candidates

End-tidal CO2 will be measured day before surgery. Post-operative cardiovascular and pulmonary complications will be monitored fron the hospital stay, or first 30 days.

干预措施: end-tidal CO2 measurement (Diagnostic Test)

结局指标

主要结局

post-operative complications

时间窗: first 30-post operative days

cardiovascular complications

pulmonary complications

时间窗: first 30-post operative days

post-operative complications

次要结局

  • hospital length of stay(up to 30 days)
  • intensive care unit length of stay(up to 30 days)
  • mortality(from the first 30-post operative days)

研究者

发起方
St. Anne's University Hospital Brno, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivan Cundrle

Clinical Professor

St. Anne's University Hospital Brno, Czech Republic

研究点 (2)

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