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临床试验/NCT02860754
NCT02860754Unknown不适用

The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery: Prospective Cohort Study

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Measure the additive prognostic value of 6MWT to the RCRI score

研究概览

简要总结

This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac surgery. In addition, this study will assess whether the patients' reported MET score corresponds to the determined MET score from the 6MWT distance completed.

详细描述

Study investigators propose to undertake a prospective cohort study at the preoperative clinics of the Royal-Victoria and Montreal General Hospitals of McGill University Health Centre. All patients with planned noncardiac surgery under general or regional anesthesia will be considered for inclusion.

Eligible consenting patients will undergo the 6MWT during their preoperative clinical visit, typically occurring within a few weeks before surgery. This test will be performed by a trained health care worker. Patients will walk back and forth along a 20 m corridor, while attempting to cover as much ground as possible in 6 minutes. Patients will be allowed to rest on the chairs while performing the test if necessary. Patients will be encouraged to resume walking as soon as patients feel physically able. The total covered distance in 6 minutes will be measured to the nearest meter.

The RCRI score will be calculated for each study participant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • All patients fulfilling all the following inclusion criteria will be enrolled:
  • Patients aged ≥ 50 year old and undergoing elective noncardiac surgery, under general anesthesia or regional anesthesia.
  • Patients with planned surgery within 3 months of the preoperative visit.
  • Patients with at least one of the following medical conditions:
  • Hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, transient ischemic attack, stroke, or peripheral vascular disease.

排除标准

  • Patients meeting any of the following criteria will be excluded:
  • Patients with a condition preventing mobilization for 6 minutes.
  • Patients with significant cardiac disease (e.g., low-threshold angina (angina that occurs with minimal exertion), severe aortic stenosis).
  • Patients with severe pulmonary disease restricting mobility.
  • Patients refusing to participate.
  • Patients previously enrolled in the study.

研究组 & 干预措施

Six-minute walk test

Other

All patients will perform six-minute walk test before surgery, in the preoperative clinic

干预措施: Six-minute walk test to perform before surgery (Other)

结局指标

主要结局

Measure the additive prognostic value of 6MWT to the RCRI score

时间窗: At 30 day after surgery

Investigate the additive prognostic value of the 6MWT to the RCRI score for predicting major cardiovascular complications at 30 day after surgery, in patients undergoing noncardiac surgery.

次要结局

  • Compare self reported MET score to 6MWT distance(At preoperative clinic visit. Only one measure)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amal Bessissow, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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