Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
- 试验地点
- 10
- 主要终点
- Diagnostic challenge
研究概览
简要总结
The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.
Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.
详细描述
Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.
Aim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.
Methodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.
Potential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening
- •aged 40-85 years
- •at increased cardiovascular risk
- •undergoing inpatient, noncardiac, elective or emergent surgery
- •postoperative stay of ≥2 nights at the participating institution
- •orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, and visceral surgery.
排除标准
- •patients with cardiac surgery or interventions in the last 14 days
- •chronic renal failure under dialysis, renal transplant surgery
- •moderate-to-severe dementia
- •previous inclusion within 5 days
- •documented refusal to use of their data for research purposes or refusal of further use during follow-up
- •Patients declining consent for follow-up will be excluded from follow-up analyses.
结局指标
主要结局
Diagnostic challenge
时间窗: during hospital stay (up to postoperative day 5)
Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated
Incidence of PMI
时间窗: after the surgery until postoperative day 2
Percentage of patients experiencing PMI following noncardiac surgery
Cardiology consultation (Fidelity)
时间窗: during hospital stay (up to postoperative day 5)
Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist
Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)
时间窗: during the hospital stay (up to postoperative day 2)
Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)
Barriers to implementation
时间窗: following the post-implementation period (6 months after implementation)
Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology
次要结局
- Resource Usage(Within 3 - 30 days following surgery)
- Complications of cardiology diagnostics(30 days)
- Medicoeconomic impact(Within 3 - 30 days following surgery)
- Major bleeding(Postoperative day 1 - 1 year (blinding of first 24h following surgery))
- Major adverse cardiac events (MACE)(1 year)