跳至主要内容
临床试验/NCT05968456
NCT05968456招募中不适用

Complexity and Frailty in Cardiothoracic and Vascular Anesthesia (CAfCA). Prospective Multicentric Observational Study

Istituto Clinico Humanitas8 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
8
主要终点
Frailty Prevalence

研究概览

简要总结

Frailty is a multidimensional syndrome characterized by a decline in physiological homeostatic reserve, which translates into an increased susceptibility to adverse events and unfavorable outcomes following even small exposures to physical, physiological or psychosocial stress.

In the European population up to 69 years, the prevalence is generally 6,5%, beyond 85 years of age it exceeds 50% and reaches 65% in the over-ninety population. The prevalence of frailty in the surgical population varies, depending on the studies, from 10 to 40%. Frailty and its severity grade represent themselves noticeably as strong predictors of adverse postoperative outcomes. The strongest evidence of association is recorded between frailty and mortality at 30 days.

The purpose of this study is to describe the characteristics of patients undergoing anesthesia for cardiothoracic and vascular surgery, with a specific focus on frailty elements and associated comorbidities that necessitate surgery.

This data analysis will provide valuable insights into the interaction between frailty, multimorbidity, and the perioperative pathway of patients undergoing cardiothoracic and vascular anesthesia.

详细描述

The Western population is going through a rapid process of aging, which is of major relevance for perioperative medicine because it is associated with an increase of approximately 2,5 times in postoperative morbidity and mortality. Despite the clear association between advanced age and adverse outcomes, there is a significant variability of outcomes in older patients which is not explainable solely based on the differences in age and comorbidities. In this regard, frailty seems to play a key role to explain such variability. Frailty is a multidimensional syndrome characterized by a decline in physiological homeostatic reserve, which translates into an increased susceptibility to adverse events and unfavorable outcomes following even small exposures to physical, physiological or psychosocial stress. However, frailty has not to be considered exclusively in a geriatric context. Several studies conducted in intensive care and perioperative settings have observed a not negligible prevalence of frailty also in age groups below 65 years.

In the European population up to 69 years, the prevalence is generally 6,5%, beyond 85 years of age it exceeds 50% and reaches 65% in the over-ninety population. The prevalence of frailty in the surgical population varies, depending on the studies, from 10 to 40%. Such variability is determined by several factors: the tools and thresholds used to define frailty, the type of surgery, the type of procedure within the same surgical specialty and the setting of surgery. In cardiac surgery, prevalences oscillating between 10 and 50% have been reported. In vascular surgery, the prevalence of frailty is on average high oscillating between 20 and 60%, while in the field of thoracic surgery data of prevalence stands around 12 and 50%.

Frailty and its severity grade represent themselves noticeably as strong predictors of adverse postoperative outcomes. The strongest evidence of association is recorded between frailty and mortality at 30 days (Odds Ration variable between 1.4 and 8.33).

In the physio-pathological processes that link frailty to adverse postoperative outcomes, there are certainly modifiable factors. Several data in the literature demonstrate this correlation, including the evidence that patients diagnosed with frailty, if subjected to major elective surgery in centers with low volumes of fragile patients, have lower rates of survival at 30 days and a higher incidence of mortality correlated to postoperative complications, other conditions being equal.

From what has been outlined, it is easy to understand how a better knowledge of frailty and its prevalence can be useful for health systems that have to be more and more structured with the availability of clinical and organizational resources appropriate for the increasing complexity and frailty of patients.

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

  • Patients scheduled for elective cardiac, thoracic or vascular surgery
  • Patients aged 18 or older
  • Patients who have provided informed consent to participate in the study.

排除标准

  • Patients subjected to surgery in urgency and emergency settings
  • Procedures in one-day surgery settings
  • Procedures without the involvement of anesthesiologists

结局指标

主要结局

Frailty Prevalence

时间窗: at preoperative evaluation visit

Determine the prevalence of frailty in the sample using the Clinical Frailty Score, in the three clinical areas: cardiac, thoracic, and vascular surgery

Frailty Prevalence comparison

时间窗: at preoperative evaluation visit

Frailty prevalence comparison among the three clinical areas: cardiac, thoracic, and vascular surgery

次要结局

  • In-hospital complications(up to 30 days after operation)
  • Unplanned ICU admission(up to 30 days after operation)
  • Association between different frailty risk scores and clinical outcomes(up to 30 days after operation)
  • Length of hospital stay(up to 30 days after operation)
  • In-hospital mortality(up to 30 days after operation)
  • Frailty assessment instruments comparison(at preoperative evaluation visit)
  • Multimorbidity description(at preoperative evaluation visit)
  • 30-day mortality(up to 30 days after operation)
  • Correlation between perioperative risk scores and frailty scores(at preoperative evaluation visit)
  • Description of the perioperative clinical pathway(up to 30 days after operation)
  • Description of the anesthesiologic techniques adopted(up to 30 days after operation)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Piccioni

Head of Anesthesia Section 1

Istituto Clinico Humanitas

研究点 (8)

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