Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Feasibility of implementing CPVA testing in thoracic surgery patients
研究概览
简要总结
Major thoracic surgery is high risk as it carries a significant risk of postoperative Adverse Events (AEs), where patients experience complications and do not recover as expected. These AEs can increase the risk of mortality, hospital length of stay, as well as healthcare costs. The investigators' aim is to improve surgical safety by pioneering a marked advance in preoperative prediction of postoperative AEs that will enable individualized targeted perioperative pathways to prevent postoperative AEs. Given that illness and stress are associated with a loss in physiologic variability (e.g. heart and respiration rate), the investigators will use heart and lung variability assessments to improve prediction of postoperative AEs. Therefore, this study aims to assess the feasibility of implementing a preoperative CardioPulmonary variability assessment; determine if preoperative CardioPulmonary variability is associated with postoperative AEs; and determine if this variability assessment is superior and complementary to existing measures of risk and frailty.
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
- •Adult patient (≥18 years of age)
- •Patients undergoing major thoracic resection for lung, esophageal or gastric cancer or mediastinal tumour (at least lobectomy, pneumonectomy, esophagectomy, gastrectomy, or mediastinal tumour resection)
排除标准
- •Urgent/emergent cases
- •Patients with pre-existing atrial fibrillation or arrhythmia (persistent/paroxysmal)
- •Patients that are pacemaker dependent
- •Patients unable to participate in preoperative testing protocol (CardioPulmonary Variability Assessment)
- •Patients that are pregnant
结局指标
主要结局
Feasibility of implementing CPVA testing in thoracic surgery patients
时间窗: Upon study completion, 10 months after study initiation
Implementing CPVA testing in thoracic surgery patients will be considered feasible if: \>50% of identified eligible patients are enrolled and consented, \>90% of consented and enrolled patients complete CPVA testing protocol There is adequate data analysis from the CPVA in \>90% of patients that complete the CPVA protocol \>95% of CRFs are complete
Statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs
时间窗: Upon study completion, 10 months after study initiation
The statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs will be determined by separating the patient's into subgroups based on (a) any AEs (any class), (b) serious AEs (Class III and above), (c) the type of AEs they experience (including POPCs, atrial fibrillation, air leak) and performing statistical analyses to determine if there is a significance between patients who experience AEs and those who don't based on the CPVA metrics.
次要结局
- Assess predictive power of CPVA indices(Upon study completion, 10 months after study initiation)