跳至主要内容
临床试验/NCT03866915
NCT03866915Unknown不适用

Validity of Aortic Pulse Wave Velocity in Predicting the 6- Minute Walking Test Before Major Non-cardiac Surgery (6WAVE)

Grupo Español de Rehabilitación Multimodal3 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
125
试验地点
3
主要终点
AoPWV validity: relationship between AoPWV and 6MWT distance

研究概览

简要总结

Methods: Prospective observational study in adult patients requiring preoperative evaluation

Objectives: To determine the correlation between the aortic pulse wave velocity (AoPWV) and the distance walked in the 6-minute walk test (6MWT) Sample Size: For a desired precision of estimate of ± 0.10 (95% confidence interval) around a postulated validity correlation coefficient of r = 0.70 (for an AoPWV in the distance prediction of 6MWT) a sample of 100 patients. By allowing a 25% wear rate, a final sample size of 125 participants is required Inclusion criteria: Patients older than 18 years undergoing any surgery and who require pre-anesthesia Statistical analysis If the variables have a normal distribution, the Pearson correlation coefficient (r2) is used, which is between -1 and 1. Where -1 indicates the highest possible negative linear relationship (increasing the value of a variable decreases the another), 0 that there is no association, +1 positive correlation. From 0.7 negative or positive, it is said that the association is strong.

Linear regression models of ordinary least squares will be applied to obtain the validity coefficient (r) and the standard error of the estimate (SEE): the typical error associated with the prediction the AoPWV with the distance traveled in the 6MWD test in each individual patient. The analysis of the receiver operating characteristic curve (ROC) will be used to derive cutoff points for an AoPWV value for the prediction of a 6MWD less than 427 meters

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients older than 18 years undergoing elective surgery that receive a preoperative visit by anesthesiologists.

排除标准

  • Patients undergoing emergency surgery
  • Patients under 18 years of age
  • Patients who refuse to participate
  • Patients unable to perform the 6MWT
  • Claudication of the lower extremities and inability to maintain a constant pace of walking on level ground

结局指标

主要结局

AoPWV validity: relationship between AoPWV and 6MWT distance

时间窗: 1 day

The validity of AoPWV-physiological parameter measured non-invasively by photoplethysmography-will be evaluated to predict the distance traveled in 6MWT in adult patients undergoing any type of elective surgery

次要结局

  • AoPWV threshold(1 day)

研究者

发起方
Grupo Español de Rehabilitación Multimodal
申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验