Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery.
研究概览
简要总结
Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.
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
- •Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer
- •Undergoing CPET as part of routine pre-operative investigations
排除标准
- •Subjects unable to give voluntary written informed consent to participate in this study
- •Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve
- •Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation
- •Permanent pacemaker or cardiac resynchronisation device in situ
- •Diagnosis of severe pulmonary hypertension
- •Permanent atrial fibrillation
结局指标
主要结局
Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery.
时间窗: End of Trial (9 months)
Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak.
次要结局
- Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.(End of Trial (9 months))
- Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak(End of Trial (9 months))
- Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research(End of Trial (9 months))
- Assess the relationship between Seismofit® -estimated VO2 peak and other CPET derived variables: o Anaerobic Threshold (AT) o Peak Power Output (PPO) o Ventilatory equivalents for carbon dioxide (VE/VCO2)(End of Trial (9 months))