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临床试验/NCT05561608
NCT05561608已完成不适用

Validation of Heart Rate Recovery as a Peri-operative Risk Measure (VERVE)

University of Glasgow3 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
3
主要终点
Post-operative myocardial injury

研究概览

简要总结

Is heart rate recovery after submaximal exercise (i.e. not to exhaustion) a valid risk measure for post-operative outcomes?

详细描述

There are approximately 1.5 million major operations carried out in the NHS every year. As the population ages, and surgical technique becomes more advanced, more patients are undergoing operations which carry a high risk of complications. Currently, doctors predict this risk by asking patients about medical problems and their level of physical fitness. If an operation is very high risk, a patient may undergo cardiopulmonary exercise testing (CPET) where the patient rides an exercise bike to maximum effort (exhaustion) whilst their heart and lung function is measured. This gives the doctor specific numbers which can be discussed with the patient about the risk of complications after surgery. However, CPET is expensive and not all patients are able to do it, for example due to joint or circulation problems. Patients can also find attempting to reach maximal effort demanding and uncomfortable.

Heart rate recovery (HRR) after maximal exercise has been shown to indicate post-operative risk of complications, and is also related to life-expectancy in people with heart failure. The utility of HRR after submaximal exercise however has not been investigated as extensively. One group demonstrated that submaximal HRR predicts post-operative complications after lung surgery, and submaximal HRR also predicts life-expectancy in healthy individuals. There is less information about submaximal HRR as the methods of measuring it are not standardised. Previous work by our group has confirmed the reproducibility of submaximal HRR in a healthy population, and demonstrated different ways in which to measure it. The investigators believe that submaximal HRR provides a "middle-ground" method of assessing how fit a patient is for surgery.

With informed consent, 95 patients across four hospitals in the West of Scotland will perform a step test pre-operatively. The step test will involve non-invasive measurement of the heart rate. Patients will exercise until approximately two-thirds of their predicted maximum heart rate is reached and then recover sitting, whilst the rate of their heart rate recovery is recorded. Patients will have pre- and post-operative troponin values measured (blood marker of strain/injury to the heart). Alongside the blood tests, patients will also answer questionnaires related to their quality of life, and information regarding other post-operative complications will be recorded.

The study aims to demonstrate that submaximal HRR is predictive of post-operative myocardial injury (stress/injury to the heart wall due to the body's response to the operation) and that is it a valid measure when compared to the scores, blood tests and exercise tests that are currently in use in the NHS. In the future, submaximal exercise testing with HRR measurement may be offered to patients unable to perform CPET and will guide shared decision-making between patient, surgeon and anaesthetist to ensure the best outcome for the patient regarding their surgical options.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of informed consent
  • Age 50 years or over
  • Able to walk unaided
  • Planned elective intermediate/high risk surgery as defined by the ESC/ESA guidelines (i.e. >1% risk of mortality)

排除标准

  • Pregnancy
  • Ongoing participation in any investigational research which could undermine the scientific basis of the study
  • Presence of any of the American Thoracic Society's contraindications to exercise testing
  • Previous intermediate/high risk surgery within three months prior to recruitment
  • Previous participation in the VERVE study at any time

结局指标

主要结局

Post-operative myocardial injury

时间窗: 48 hours post-operatively

Post-operative troponin over the 99th centile upper reference limit plus a 20% change (increase or decrease)

次要结局

  • Major adverse kidney events(30 days post-operatively)
  • EQ-5D-5L(30 days and 1 year post-operatively)
  • Length of hospital stay (with/without hospital mortality)(Up to 1 year post-operatively)
  • Acute Kidney Injury(1 week post-operatively)
  • Cardiovascular complications(7 days post-operatively)
  • Major adverse cardiac events(30 days post-operatively)
  • Quality of recovery scale - 15(2 days post-operatively)
  • Admission/re-admission to Intensive Care(14 days post-operatively)
  • Mortality(Day 30, day 90 and 1 year post-operatively)
  • Infective complications(7 days post-operatively)
  • Neurological complications(7 days post-operatively)
  • Pulmonary complications(7 days post-operatively)
  • Days alive and out of hospital(30 days post-operatively)
  • Readmission to hospital(Within 30 days post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Ben Shelley

Honorary Clinical Associate Professor/Consultant in Cardiothoracic Anaesthesia and Intensive Care

University of Glasgow

研究点 (3)

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